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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/NCT01943799
Registration number
NCT01943799
Ethics application status
Date submitted
12/09/2013
Date registered
17/09/2013
Date last updated
1/11/2019
Titles & IDs
Public title
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
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Scientific title
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B
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Secondary ID [1]
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GS-US-330-0101
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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 HBV Infection
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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
Other interventions - GS-4774
Treatment: Drugs - OAV Regimen
Experimental: OAV Alone - Participants will continue their prebaseline OAV regimen alone from baseline to Week 48.
Experimental: OAV + GS-4774 2 YU - Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20.
Experimental: OAV + GS-4774 10 YU - Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.
Experimental: OAV + GS-4774 40 YU - Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
Other interventions: GS-4774
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
Treatment: Drugs: OAV Regimen
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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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Change From Baseline in HBsAg at Week 24
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Assessment method [1]
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The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included included treatment, HBsAg baseline level (= 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), 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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Change From Baseline in HBsAg at Week 12
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Assessment method [1]
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The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (= 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), 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 12
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Secondary outcome [2]
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Change From Baseline in HBsAg at Week 48
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Assessment method [2]
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The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (= 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
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Timepoint [2]
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Baseline; Week 48
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Secondary outcome [3]
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Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
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Assessment method [3]
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HBsAg loss was defined as HBsAg level decreasing from >0.066 IU/mL at baseline to = 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from < 12 mIU/mL at baseline to = 12 mIU/mL at any postbaseline visit.
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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 HBsAg Seroconversion at Week 48
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Assessment method [4]
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HBsAg loss was defined as HBsAg level decreasing from >0.066 IU/mL at baseline to = 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from < 12 mIU/mL at baseline to = 12 mIU/mL at any postbaseline visit.
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24
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Assessment method [5]
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HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48
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Assessment method [6]
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HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.
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Timepoint [6]
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Week 48
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Secondary outcome [7]
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Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48
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Assessment method [7]
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HBsAg 1-log decline was defined as = 1 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
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Timepoint [7]
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Baseline; Weeks 12, 24, and 48
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Eligibility
Key inclusion criteria
Key
- Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures
- Currently taking an approved HBV oral antiviral medication
- Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6
months)
- Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for = 1
year)
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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
- Cirrhosis
- Inadequate liver function
- Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV)
- Evidence of hepatocellular carcinoma
- Significant cardiovascular, pulmonary, or neurological disease
- Females who are pregnant or may wish to become pregnant during the study
- Received solid organ or bone marrow transplant
- Use of another investigational agents within 3 months of screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere
with compliance
- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease
ulcerative colitis, autoimmune disease
- Known hypersensitivity to study drug, metabolites or formulation excipients
- Malignancy within 5 years prior to screening, with the exception of specific cancers
that are cured by surgical resection (basal cell skin cancer, etc). Participants under
evaluation for possible malignancy are not eligible.
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
Open (masking not used)
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Who is / are masked / blinded?
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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
13/09/2013
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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
3/03/2015
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Sample size
Target
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Accrual to date
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Final
178
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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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United States of America
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State/province [2]
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Florida
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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Missouri
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United States of America
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New York
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Virginia
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New Zealand
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State/province [10]
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Grafton
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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 and efficacy of GS-4774 in
adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with
an oral antiviral (OAV) medication.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01943799
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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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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/NCT01943799
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