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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/NCT02579382
Registration number
NCT02579382
Ethics application status
Date submitted
15/10/2015
Date registered
19/10/2015
Date last updated
18/05/2020
Titles & IDs
Public title
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
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Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
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Secondary ID [1]
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2015-002017-30
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Secondary ID [2]
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GS-US-283-1062
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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:
Chronic Hepatitis B
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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 - TDF
Treatment: Drugs - Vesatolimod
Treatment: Drugs - Placebo
Placebo Comparator: TDF + placebo - Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
Experimental: TDF + Vesatolimod 1 mg - Main Study Phase:TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
Experimental: TDF + Vesatolimod 2 mg - Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
Experimental: TDF + Vesatolimod 4 mg - Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.
Treatment: Drugs: TDF
300 mg tablets administered orally once daily
Treatment: Drugs: Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses
Treatment: Drugs: Placebo
Placebo administered orally once a week (every 7 days) for 12 doses
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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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Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24
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Assessment method [1]
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The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (> 19 vs = 19 IU/L for females; > 30 vs = 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.
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Timepoint [1]
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Baseline; Week 24
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Secondary outcome [1]
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Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
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Assessment method [1]
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HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative Hepatitis B Envelope Antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
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Assessment method [2]
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HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
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Timepoint [2]
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Week 48
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Secondary outcome [3]
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Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
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Assessment method [3]
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HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative Hepatitis B Surface Antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
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Assessment method [4]
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HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
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Assessment method [5]
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Timepoint [5]
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Baseline; Week 12
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Secondary outcome [6]
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Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48
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Assessment method [6]
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Timepoint [6]
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Baseline; Week 48
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Secondary outcome [7]
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Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
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Assessment method [7]
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HBsAg = 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg = 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
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Timepoint [7]
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Baseline to Week 12
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Secondary outcome [8]
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Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
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Assessment method [8]
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HBsAg = 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg = 0.5 at the Week 24 post-baseline visit.
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Timepoint [8]
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Baseline to Week 24
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Secondary outcome [9]
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Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
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Assessment method [9]
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HBsAg = 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg = 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
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Timepoint [9]
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Baseline to Week 48
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Secondary outcome [10]
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Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24
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Assessment method [10]
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LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
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Timepoint [10]
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Week 24
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Secondary outcome [11]
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Percentage of Participants With HBV DNA < LLOQ at Week 48
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Assessment method [11]
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LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
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Timepoint [11]
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Week 48
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Secondary outcome [12]
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Percentage of Participants Experiencing Virologic Breakthrough
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Assessment method [12]
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Virologic breakthrough was defined as confirmed HBV DNA = 69 IU/mL after having had HBV DNA < 69 IU/mL or confirmed 1.0 log10 IU/mL or greater increase in HBV DNA from nadir. Confirmation requires 2 consecutive occurrences of elevation in HBV DNA to > 69 IU/mL after having had HBV DNA < 69 IU/mL or 1.0 log10 IU/mL or greater increases in HBV DNA from nadir.
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Timepoint [12]
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Weeks 24 and 48
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Secondary outcome [13]
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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
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Assessment method [13]
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Sequence analysis of the HBV pol/RT was attempted for any participant who had HBV DNA = 69 IU/mL at Week 48 or early discontinuation. Results of the alignment of Week 48 and baseline sequence were reported as a change from baseline sequence.
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Timepoint [13]
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Baseline; Week 48
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Secondary outcome [14]
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Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
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Assessment method [14]
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AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
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Timepoint [14]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Secondary outcome [15]
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PK Parameter: AUCinf of Vesatolimod
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Assessment method [15]
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AUCinf is defined as the concentration of drug extrapolated to infinite time.
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Timepoint [15]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Secondary outcome [16]
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PK Parameter: %AUCexp of Vesatolimod
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Assessment method [16]
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%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.
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Timepoint [16]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Secondary outcome [17]
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PK Parameter: Cmax of Vesatolimod
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Assessment method [17]
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Cmax is defined as the maximum concentration of drug.
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Timepoint [17]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Secondary outcome [18]
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PK Parameter: Clast of Vesatolimod
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Assessment method [18]
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Clast is defined as the last observable concentration of drug.
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Timepoint [18]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Secondary outcome [19]
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PK Parameter: Tmax of Vesatolimod
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Assessment method [19]
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Tmax is defined as the time (observed time point) of Cmax
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Timepoint [19]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Secondary outcome [20]
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PK Parameter: Tlast of Vesatolimod
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Assessment method [20]
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Tlast is defined as the time (observed time point) of Clast.
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Timepoint [20]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Secondary outcome [21]
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PK Parameter: T1/2 of Vesatolimod
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Assessment method [21]
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T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
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Timepoint [21]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Secondary outcome [22]
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PK Parameter: CL/F of Vesatolimod
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Assessment method [22]
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CL/F is defined as the apparent oral clearance following administration of the drug.
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Timepoint [22]
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Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
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Eligibility
Key inclusion criteria
Key
- Adult males or females between the ages of 18-65
- Chronic hepatitis B virus (HBV) infection
- HBV deoxyribonucleic acid (DNA ) = 2000 IU/mL at screening
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Minimum age
18
Years
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Maximum age
65
Years
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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
- Extensive bridging fibrosis or cirrhosis
- Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators
or biologics within 3 months of screening
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or
hepatitis D virus (HDV)
- Chronic liver disease other than HBV
- Lactating or pregnant females or those that wish to become pregnant during the course
of the study
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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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 analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
10/11/2015
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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
3/05/2019
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Sample size
Target
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Accrual to date
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Final
192
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Recruitment in Australia
Recruitment state(s)
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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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Hawaii
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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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Maryland
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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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Massachusetts
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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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New York
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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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Pennsylvania
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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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Hong Kong
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State/province [8]
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Kowloon
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Country [9]
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Italy
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State/province [9]
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Bologna
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Country [10]
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Italy
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State/province [10]
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Milano
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Country [11]
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Italy
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State/province [11]
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Pisa
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Country [12]
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Italy
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State/province [12]
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San Giovanni Rotondo
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Country [13]
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Korea, Republic of
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State/province [13]
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Daegu
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Country [14]
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Korea, Republic of
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State/province [14]
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Seoul
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Country [15]
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New Zealand
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State/province [15]
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Auckland
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Country [16]
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Taiwan
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State/province [16]
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Dalin
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Country [17]
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Taiwan
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State/province [17]
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Kaohsiung
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Country [18]
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United Kingdom
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State/province [18]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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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 primary objectives of this study are to evaluate the safety, tolerability, and efficacy
of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are
currently not being treated.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02579382
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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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Gilead Study Director
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Address
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Gilead Sciences
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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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Country
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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/NCT02579382
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