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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00516321
Registration number
NCT00516321
Ethics application status
Date submitted
13/08/2007
Date registered
15/08/2007
Date last updated
5/11/2013
Titles & IDs
Public title
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease
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Scientific title
Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin
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Secondary ID [1]
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TPL103922
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - eltrombopag
Treatment: Drugs - placebo
Treatment: Drugs: eltrombopag
25, 50, 75, 100 mg tablets taken once daily orally
Treatment: Drugs: placebo
matched placebo taken once daily orally
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase
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Assessment method [1]
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Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the treatment period of the DB Phase.
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Timepoint [1]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [1]
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Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase
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Assessment method [1]
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Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=90 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.
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Timepoint [1]
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From Baseline up to Week 9 in the OL Phase
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Secondary outcome [2]
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Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase
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Assessment method [2]
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In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <90 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <90 Gi/L. Participants who achieved platelet count >=90 Gi/L on any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.
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Timepoint [2]
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From Baseline up to Week 9 in the OL Phase
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Secondary outcome [3]
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Median Platelet Count at the Indicated Time Points During the OL Phase
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Assessment method [3]
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Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
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Timepoint [3]
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OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)
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Secondary outcome [4]
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Median Platelet Count at the Indicated Time Points During the DB Phase
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Assessment method [4]
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Blood taken from peripheral blood vessels was used for the measurement of platelet counts.
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Timepoint [4]
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DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
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Secondary outcome [5]
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Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase
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Assessment method [5]
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The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.
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Timepoint [5]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [6]
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Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase
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Assessment method [6]
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RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.
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Timepoint [6]
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From Baseline up to Week 12
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Secondary outcome [7]
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Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase
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Assessment method [7]
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EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.
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Timepoint [7]
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From Baseline up to Week 12
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Secondary outcome [8]
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Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase
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Assessment method [8]
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ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.
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Timepoint [8]
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From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3)
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Secondary outcome [9]
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Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase
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Assessment method [9]
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Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.
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Timepoint [9]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [10]
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Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase
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Assessment method [10]
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Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.
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Timepoint [10]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [11]
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Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase
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Assessment method [11]
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The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (mcg). For peginterferon dose modification, downward adjustments in one level increments was considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 mcg. Where dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 mcg was generally adequate. In some cases, a dose reduction to 90 mcg or 45mcg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.
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Timepoint [11]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [12]
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Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase
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Assessment method [12]
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The following participants were considered to have discontinued from antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.
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Timepoint [12]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [13]
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Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase
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Assessment method [13]
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There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. Genotyping of the IL28B polymorphisms (rs12979860 and rs8099917) was conducted. IL28B genotype distribution by response to antiviral therapy (SVR and RVR) for both treatment arms was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.
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Timepoint [13]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [14]
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Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase
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Assessment method [14]
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Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
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Timepoint [14]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [15]
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Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase
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Assessment method [15]
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Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
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Timepoint [15]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [16]
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Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase
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Assessment method [16]
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Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.
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Timepoint [16]
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From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
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Secondary outcome [17]
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Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase
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Assessment method [17]
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Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The investigator assigned an ECG status of normal, abnormal, CS, or NCS; a status of "abnormal" alone indicates that the investigator did not determine if ECG was CS or NCS. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.
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Timepoint [17]
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DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
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Secondary outcome [18]
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Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase
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Assessment method [18]
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Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS or a NCS change from baseline in ECG status was reported, as determined by the Investigator based on a reasonable standard of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.
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Timepoint [18]
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End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
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Secondary outcome [19]
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Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase
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Assessment method [19]
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Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
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Timepoint [19]
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DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
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Secondary outcome [20]
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Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase
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Assessment method [20]
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Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
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Timepoint [20]
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DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
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Secondary outcome [21]
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Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase
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Assessment method [21]
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The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
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Timepoint [21]
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DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
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Secondary outcome [22]
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Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase
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Assessment method [22]
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The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
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Timepoint [22]
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DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
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Eligibility
Key inclusion criteria
Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection
Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral
therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for
women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with
neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two
forms of effective contraception between them during treatment and during the 24 weeks
after treatment end Subject is able to understand, consent and comply with protocol
requirements and instructions and is likely to complete the study as planned
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a
sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an
optimal course (dose and duration) of combination therapy with pegIFN and ribavirin
Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic
encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or
allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious
cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN
and ribavirin
Subjects with a history of any one of the following:
Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or
poorly controlled psychiatric disorder
The following subjects are eligible for study participation, but must be assessed and
followed (if recommended) by a mental health professional:
- Subjects who have had a severe or poorly controlled psychiatric disorder more than 6
months ago but less than 5 years ago
- Seizure disorder that has not been well controlled History of clinically significant
bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g.
sickle cell anaemia, thalassemia major Any prior history of arterial or venous
thrombosis AND two or more of the following risk factors: hereditary thrombophilic
disorders (e.g. Factor V Leiden, antithrombin III (ATIII) deficiency, etc), hormone
replacement therapy, systemic contraception (containing estrogen), smoking, diabetes,
hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac
disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to
involve the risk of thromboembolic events, or corrected QT interval (QTc) >450 msec
Evidence of hepatocellular carcinoma Laboratory evidence of infection with human
immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease
condition associated with active bleeding or requiring anticoagulation with heparin or
warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment <6 months
prior to the first dose of eltrombopag Subjects who have had a malignancy diagnosed
and/or treated within the past 5 years, except for subjects with localised basal or
squamous cell carcinoma treated by local excision or subjects with malignancies who
have been adequately treated and, in the opinion of the oncologist, have an excellent
chance of cancer-free survival Pregnant or nursing women Males with a female partner
who is pregnant History of alcohol/drug abuse or dependence within 6 months of the
study start (unless participating in a controlled rehabilitation programme) Treatment
with an investigational drug or IFN within 30 days or 5 half-lives (whichever is
longer) of the screening visit History of platelet clumping that prevents reliable
measurement of platelet counts History of major organ transplantation with an existing
functional graft Thyroid dysfunction not adequately controlled Subjects planning to
have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3
months of the baseline visit
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2011
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Sample size
Target
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Accrual to date
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Final
687
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
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Recruitment hospital [1]
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0
GSK Investigational Site - Garran
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Recruitment hospital [2]
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GSK Investigational Site - Camperdown
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Recruitment hospital [3]
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GSK Investigational Site - Randwick
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Recruitment hospital [4]
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GSK Investigational Site - Fitzroy
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Recruitment hospital [5]
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GSK Investigational Site - Heidelberg
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Recruitment hospital [6]
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GSK Investigational Site - Melbourne
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Recruitment hospital [7]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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0
2606 - Garran
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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3168 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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Alabama
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0
0
United States of America
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State/province [2]
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Arizona
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United States of America
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State/province [3]
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Arkansas
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0
United States of America
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State/province [4]
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California
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Country [5]
0
0
United States of America
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State/province [5]
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Colorado
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0
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United States of America
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State/province [6]
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Connecticut
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United States of America
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State/province [7]
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District of Columbia
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0
United States of America
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State/province [8]
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Florida
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Country [9]
0
0
United States of America
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State/province [9]
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Georgia
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Country [10]
0
0
United States of America
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State/province [10]
0
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Hawaii
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Kentucky
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Country [12]
0
0
United States of America
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State/province [12]
0
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Maryland
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Country [13]
0
0
United States of America
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State/province [13]
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Massachusetts
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Country [14]
0
0
United States of America
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State/province [14]
0
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Michigan
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Mississippi
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Country [16]
0
0
United States of America
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State/province [16]
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Missouri
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Country [17]
0
0
United States of America
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State/province [17]
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New York
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Country [18]
0
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United States of America
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State/province [18]
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North Carolina
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Funding & Sponsors
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Commercial sector/Industry
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Name
GlaxoSmithKline
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Summary
Brief summary
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet
count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy
dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical
benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve
a Sustained Virological Response (SVR).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00516321
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00516321
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