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NCT01740791 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
A Phase 1 study of Chronic Hepatitis C Virus, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
- 10
- Study locations
NCT01740791: Completed Phase 1 study of Chronic Hepatitis C Virus, sponsored by Gilead Sciences.
NCT01740791 is a Phase 1 study of Chronic Hepatitis C Virus that has completed, run by Gilead Sciences. The registered enrollment target is 103 participants, below the 329-participant average among 3 other Chronic Hepatitis C Virus trials with a reported enrollment target (69% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01740791, a Phase 1 study of Chronic Hepatitis C Virus, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.
Primary Outcome
Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Velpatasvir
Study Locations (10)
Florida
- Avail Clinical Research, LLC - DeLand
- Orlando Clinical Research Center - Orlando
California
- West Coast Clinical Trials, LLC - Costa Mesa
Missouri
- Kansas City Gastroenterology and Hepatology - Kansas City
New Jersey
- CRI Worldwide, LLC - Marlton
Pennsylvania
- CRI Worldwide, LLC - Philadelphia
Tennessee
- New Orleans Center for Clinical Research-Knoxville - Knoxville
Texas
- Alamo Medical Research - San Antonio
Washington
- Charles River Clinical Services Northwest, Inc. - Tacoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2012-11-06 |
| Est. Completion | 2014-01-24 |
| Phase | Phase 1 |
What the finished NCT01740791 record still lists
NCT01740791 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 329-participant average among 3 other Chronic Hepatitis C Virus trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Chronic Hepatitis C Virus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01740791 lists 10 locations in 9 states (Florida, California, Missouri).
Frequently Asked Questions
What is clinical trial NCT01740791 about?
NCT01740791 is a clinical study titled "Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection". The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.
What is the current status of trial NCT01740791?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2012-11-06. Estimated completion is 2014-01-24.
What conditions does trial NCT01740791 study?
This clinical trial studies the following conditions: Chronic Hepatitis C Virus.
What interventions are being tested in trial NCT01740791?
The interventions under investigation include: Placebo (DRUG), Velpatasvir (DRUG).
Who is sponsoring clinical trial NCT01740791?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01740791 being conducted?
This trial has 10 study locations across California, Florida, Missouri, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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