Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
Status: | Completed |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 5/3/2014 |
Start Date: | September 2013 |
End Date: | March 2015 |
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
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.
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.
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.
We found this trial at
16
sites
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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University of Miami A private research university with more than 15,000 students from around the...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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