本帖最后由 StephenW 于 2013-12-2 16:07 编辑
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B This study is currently recruiting participants.
Verified November 2013 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01943799
First received: September 12, 2013
Last updated: November 14, 2013
Last verified: November 2013
Purpose This is a randomized, open-label, multicenter Phase 2 study to evaluate the safety and efficacy of GS-4774 in subjects with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral medication. One hundred and seventy-five subjects will be randomized in a 1:2:2:2 ratio to the treatment arms for 20 weeks.
Study Type: | Interventional | Study Design: | Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment | 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 |
Resource links provided by NLM:
MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B
Drug Information available for: Recombinant Hepatitis B vaccine Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures: - Mean change in log10 IU/mL serum hepatitis B surface antigen (HBsAg) from Baseline to Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures: - Mean change in log10 IU/mL serum HBsAg from Baseline to Weeks 12 and 48 [ Time Frame: Baseline to Weeks 12 and 48 ] [ Designated as safety issue: No ]
- Proportion of participants with HBsAg loss and HBsAg seroconversion at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Proportion of participants with hepatitis B e antigen (HBeAg) loss and HBeAg seroconversion at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Proportion of participants with a 1-log decline in HBsAg at Weeks 12, 24, and 48 [ Time Frame: Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]
Estimated Enrollment: | 175 | Study Start Date: | September 2013 | Estimated Study Completion Date: | March 2015 | Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) | Arms | Assigned Interventions | Experimental: OAV AloneParticipants will continue their prebaseline OAV treatment alone from baseline to Week 48.
| Drug: OAV RegimenOral antiviral (OAV) regimen as administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
| Experimental: OAV + GS-4774 2 YUParticipants will continue their prebaseline OAV from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20.
| Biological: GS-4774GS-4774 2, 10, or 40 YU administered as a subcutaneous injection every 4 weeks for a total of 6 doses
Drug: OAV RegimenOral antiviral (OAV) regimen as administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
| Experimental: OAV + GS-4774 10 YUParticipants will continue their prebaseline OAV from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.
| Biological: GS-4774GS-4774 2, 10, or 40 YU administered as a subcutaneous injection every 4 weeks for a total of 6 doses
Drug: OAV RegimenOral antiviral (OAV) regimen as administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
| Experimental: OAV + GS-4774 40 YUParticipants will continue their prebaseline OAV from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
| Biological: GS-4774GS-4774 2, 10, or 40 YU administered as a subcutaneous injection every 4 weeks for a total of 6 doses
Drug: OAV RegimenOral antiviral (OAV) regimen as administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
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Eligibility
Ages Eligible for Study: | 18 Years to 65 Years | Genders Eligible for Study: | Both | Accepts Healthy Volunteers: | No | Criteria
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)
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.
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