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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/NCT00996216
Registration number
NCT00996216
Ethics application status
Date submitted
1/10/2009
Date registered
16/10/2009
Date last updated
6/12/2013
Titles & IDs
Public title
Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390
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Scientific title
An Open-label, Multi-centre Rollover Study to Assess the Safety and Efficacy of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a or Peginterferon Alfa-2b Plus Ribavirin)
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Secondary ID [1]
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108392
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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
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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 - Antiviral therapy
Experimental: Open-label eltrombopag - Open-label eltrombopag with dose titrations to support adequate platelet counts.
Treatment: Drugs: Eltrombopag
Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.
Treatment: Drugs: Antiviral therapy
Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.
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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 Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
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Timepoint [1]
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From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
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Primary outcome [2]
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Number of Participants With Any AE and Any SAE in Part 2
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Assessment method [2]
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
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Timepoint [2]
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From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)
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Primary outcome [3]
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Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1
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Assessment method [3]
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Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
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Timepoint [3]
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From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
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Primary outcome [4]
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Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2
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Assessment method [4]
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Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
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Timepoint [4]
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From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)
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Primary outcome [5]
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Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1
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Assessment method [5]
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Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
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Timepoint [5]
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From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
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Primary outcome [6]
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Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2
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Assessment method [6]
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Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
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Timepoint [6]
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From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)
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Primary outcome [7]
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Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2
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Assessment method [7]
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Visual acuity (VA) is defined as acuteness or clearness of vision.
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Timepoint [7]
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From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
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Primary outcome [8]
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Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2
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Assessment method [8]
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LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
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Timepoint [8]
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From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
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Primary outcome [9]
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Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2
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Assessment method [9]
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LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
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Timepoint [9]
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From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
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Secondary outcome [1]
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Platelet Counts at the Indicated Time Points
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Assessment method [1]
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Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.
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Timepoint [1]
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From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
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Secondary outcome [2]
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Number of Particpants Who Initiated Antiviral Therapy
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Assessment method [2]
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The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.
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Timepoint [2]
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From the start of the investigational product up to 9 weeks (median of 21 days)
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Secondary outcome [3]
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Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)
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Assessment method [3]
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SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.
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Timepoint [3]
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From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
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Eligibility
Key inclusion criteria
- Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24
Follow Up Visit in TPL103922 or TPL108390
- Male or female =18 years old
- Evidence of chronic HCV infection
- While participating in TPL103922 or TPL108390, discontinued from study drug due to
thrombocytopenia
- Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin
- Platelet count <75,000
- Fertile males and females must use two forms of effective contraception during
treatment and for 24 weeks after treatment
- Ability to understand and comply with the protocol requirements and instructions
- Ability to provide written informed consent
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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
- Decompensated liver disease
- Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag,
or their ingredients
- History of clinically significant bleeding from oesophageal or gastric varices
- History of arterial or venous thrombosis and two or more of the following risk
factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic
contraception (containing estrogen); smoking; diabetes; hypercholesterolemia;
medication for hypertension or cancer
- Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias
known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
- Evidence of hepatocellular carcinoma
- HIV or Hepatitis B infection
- Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to
eltrombopag therapy
- Malignancy diagnosed or treated within the past five years. Except for localized basal
or squamous cell carcinoma treated by local excision or malignancies that were
adequately treated and, in the opinion of the oncologist, have an excellent chance of
cancer-free survival.
- Pregnant or nursing women
- Men with a female partner who is pregnant
- History of alcohol/drug abuse or dependence within six months of the study start
unless participating in a controlled rehabilitation programme.
- Treatment with an investigational drug or interferon within 30 days or 5 half-lives
(whichever is longer) of the screening visit
- History or platelet clumping that prevents reliable measurement of platelet counts
- Evidence of portal vein thrombosis within three months of baseline visit
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
1/09/2009
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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
1/02/2013
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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GSK Investigational Site - Camperdown
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Recruitment hospital [2]
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GSK Investigational Site - Randwick
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Recruitment hospital [3]
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GSK Investigational Site - Herston
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Connecticut
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Country [3]
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United States of America
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State/province [3]
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Hawaii
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Tennessee
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Country [6]
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United States of America
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State/province [6]
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Washington
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Country [7]
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Canada
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State/province [7]
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Ontario
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Country [8]
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Canada
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State/province [8]
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Quebec
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Country [9]
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France
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State/province [9]
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Marseille Cedex 08
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Country [10]
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France
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State/province [10]
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Nice cedex 3
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Country [11]
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France
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State/province [11]
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Pessac Cedex
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Country [12]
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Germany
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State/province [12]
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Baden-Wuerttemberg
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Country [13]
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Germany
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State/province [13]
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Bayern
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Country [14]
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Germany
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State/province [14]
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Nordrhein-Westfalen
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Country [15]
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Germany
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State/province [15]
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Berlin
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Country [16]
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Greece
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State/province [16]
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Athens
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Country [17]
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Italy
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State/province [17]
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Emilia-Romagna
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Country [18]
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Italy
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State/province [18]
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Liguria
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Country [19]
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Italy
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State/province [19]
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Lombardia
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Country [20]
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Pakistan
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State/province [20]
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Lahore
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Country [21]
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Spain
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State/province [21]
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La Coruña
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Country [22]
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Spain
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State/province [22]
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Madrid
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Country [23]
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Spain
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State/province [23]
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Pontevedra
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Country [24]
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Spain
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State/province [24]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to test the safety and tolerability of eltrombopag when used to
increase and maintain platelet count. Platelet count to be maintained at a level sufficient
to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions,
and to avoid permanent discontinuation of antiviral therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00996216
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00996216
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