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NCT01591668 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT01591668 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 51 participants.
The verdict
NCT01591668, 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 either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.
Interventions
- DRUG Single Ascending Dose Cohorts GS-9620
- DRUG Multiple Ascending Dose Cohorts GS-9620
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01591668
The ClinicalTrials.gov registry entry for NCT01591668 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 Cohorts GS-9620 is the first listed.
NCT01591668 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01591668 about?
NCT01591668 is a clinical study titled "A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C". 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 and/or days 8-10. Follow-up visits are also required periodica...
What is the current status of trial NCT01591668?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2012-03. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01591668?
The interventions under investigation include: Single Ascending Dose Cohorts GS-9620 (DRUG), Multiple Ascending Dose Cohorts GS-9620 (DRUG).
Who is sponsoring clinical trial NCT01591668?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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