A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
Public ClinicalTrials.gov record NCT01590641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple- Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B Virus Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
Study identification
- NCT ID
- NCT01590641
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2012 (Type not available)
- Primary completion
- Sep 2013 (Actual)
- Completion
- Oct 2013 (Actual)
- Last update posted
- Nov 14, 2013
2012 – 2013
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| West Coast Clinical Trials, LLC | Costa Mesa | California | 92626 | — |
| University of California Antiviral Research Center (AVRC) | San Diego | California | 92103 | — |
| Indiana University Medical Center | Indianapolis | Indiana | 46202-5121 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70122 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84123 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01590641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 14, 2013 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01590641 live on ClinicalTrials.gov.