Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
Completed · Phase 2
Conditions studied: Chronic Hepatitis B
In brief
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.
Key facts
- Study ID
- NCT02174276
- Run by
- Gilead Sciences
- People needed
- 195
- Starts
- 2014-07-24
- Expected to finish
- 2018-05-30
- Last updated by the study team
- 2019-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stanford University Medical Center — Palo Alto, California, United States
- Kaiser Permanente — Sacramento, California, United States
- Research and Education, Inc. — San Diego, California, United States
- Kaiser Permanente San Francisco — San Francisco, California, United States
- Silicon Valley Research Institute — San Jose, California, United States
- The Queen's Medical Center — Honolulu, Hawaii, United States
- Digestive Disease Associates, PA — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Xiaoli Ma, PC — Philadelphia, Pennsylvania, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- Kaiser Permanente — Springfield, Virginia, United States
- Gordon & Leslie Diamond Health Care Centre — Vancouver, British Columbia, Canada
- Liver and Intestinal Research Center — Vancouver, British Columbia, Canada
- University of Manitoba — Winnipeg, Manitoba, Canada
- Toronto General Hospital-The University Health Network — Toronto, Ontario, Canada
- Toronto Liver Centre — Toronto, Ontario, Canada
- Toronto Western Hospital-The University Health Network — Toronto, Ontario, Canada
- Aou-S.Orsola-Malpighi - Universita Degli Studi Di — Bologna, Italy
- Azienda Ospedaliero-Universitaria di Parma — Parma, Italy
- Azienda Ospedaliero-Universitaria Pisana — Pisa, Italy
- IRCCS Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy
- Auckland Clinical Studies — Auckland, New Zealand
- Dr. Victor Babes Hospital for Infectious Diseases — Bucharest, Romania
- Institutul National de Boli Infectioase Prof.Dr. Matei Bals — Bucharest, Romania
Full record on ClinicalTrials.gov
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