Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01590654 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT01590654 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 51 participants.
The verdict
NCT01590654, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
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 days 1-3 and/or days 8-10. Follow-up visits are required periodically through day 43. Subjects with sustained reductions in HbsAg will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
Interventions
- DRUG Single Ascending Dose (SAD) Cohorts GS-9620
- DRUG Multiple Ascending Dose (MAD) Cohorts GS-9620
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01590654
The ClinicalTrials.gov registry entry for NCT01590654 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Single Ascending Dose (SAD) Cohorts GS-9620 is the first listed.
NCT01590654 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01590654 about?
NCT01590654 is a clinical study titled "A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection". 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 days 1-3 and/or days 8-10. Follow-up visits are required periodically through ...
What is the current status of trial NCT01590654?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2012-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01590654?
The interventions under investigation include: Single Ascending Dose (SAD) Cohorts GS-9620 (DRUG), Multiple Ascending Dose (MAD) Cohorts GS-9620 (DRUG).
Who is sponsoring clinical trial NCT01590654?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.