Chronic HBV Infection Clinical Trial
Official 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
Verified date | October 2019 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 178 |
Est. completion date | March 3, 2015 |
Est. primary completion date | September 9, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
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 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) 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. |
Country | Name | City | State |
---|---|---|---|
New Zealand | Auckland Clinical Studies | Grafton | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Digestive Disease Associates, PA | Baltimore | Maryland |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | Henry Ford Hospital and Health System | Detroit | Michigan |
United States | Medical Pro-care | Flushing | New York |
United States | Dumont-UCLA Liver Transplant Center | Los Angeles | California |
United States | North Shore LIJ Health System | Manhasset | New York |
United States | University of Miami | Miami | Florida |
United States | Bon Secours St. Mary's Hospital of Richmond | Newport News | Virginia |
United States | Huntington Medical Research Institutes | Pasadena | California |
United States | Kaiser Permanente | Sacramento | California |
United States | St.Louis University | Saint Louis | Missouri |
United States | Kaiser Permanente | San Diego | California |
United States | Kaiser Permanente | San Francisco | California |
United States | Silicon Valley Research Institute | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in HBsAg at Week 24 | 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. | Baseline; Week 24 | |
Secondary | Change From Baseline in HBsAg at Week 12 | 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. | Baseline; Week 12 | |
Secondary | Change From Baseline in HBsAg at Week 48 | 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. | Baseline; Week 48 | |
Secondary | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | 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. | Week 24 | |
Secondary | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | 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. | Week 48 | |
Secondary | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | 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. | Week 24 | |
Secondary | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | 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. | Week 48 | |
Secondary | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | 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. | Baseline; Weeks 12, 24, and 48 |
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