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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01943799




Registration number
NCT01943799
Ethics application status
Date submitted
12/09/2013
Date registered
17/09/2013
Date last updated
26/03/2015

Titles & IDs
Public title
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
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
Secondary ID [1] 0 0
GS-US-330-0101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic HBV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
GS-4774 2, 10, or 40 YU administered as a subcutaneous injection every 4 weeks for a total of 6 doses

Treatment: Drugs: OAV Regimen
Oral antiviral (OAV) regimen as administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in log10 IU/mL serum hepatitis B surface antigen (HBsAg) from Baseline to Week 24
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Mean change in log10 IU/mL serum HBsAg from Baseline to Weeks 12 and 48
Timepoint [1] 0 0
Baseline to Weeks 12 and 48
Secondary outcome [2] 0 0
Proportion of participants with HBsAg loss and HBsAg seroconversion at Weeks 24 and 48
Timepoint [2] 0 0
Weeks 24 and 48
Secondary outcome [3] 0 0
Proportion of participants with hepatitis B e antigen (HBeAg) loss and HBeAg seroconversion at Weeks 24 and 48
Timepoint [3] 0 0
Weeks 24 and 48
Secondary outcome [4] 0 0
Proportion of participants with a 1-log decline in HBsAg at Weeks 12, 24, and 48
Timepoint [4] 0 0
Weeks 12, 24, and 48

Eligibility
Key inclusion criteria
- Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures

- Currently taking an 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) by for = 1
year)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
New Zealand
State/province [10] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will 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 medication.
Participants will be randomized in a 1:2:2:2 ratio to the treatment arms for 20 weeks.
Trial website
https://clinicaltrials.gov/show/NCT01943799
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Benedetta Massetto, MD, PhD
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications