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NCT00703118 · ClinicalTrials.gov registry record · Phase 3
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
A Phase 3 study of Hepatitis C, Chronic, sponsored by Tibotec BVBA.
- Completed
- Registry status
- Phase 3
- Development phase
- 663
- Enrollment target
- 20
- Study locations
NCT00703118: Completed Phase 3 study of Hepatitis C, Chronic, sponsored by Tibotec BVBA.
NCT00703118 is a Phase 3 study of Hepatitis C, Chronic that has completed, run by Tibotec BVBA. The registered enrollment target is 663 participants, above the 351-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00703118, a Phase 3 study of Hepatitis C, Chronic, has completed, sponsored by Tibotec BVBA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 663 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.
Primary Outcome
SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ribavirin
- DRUG Telaprevir
- DRUG Peg-IFN-alfa-2a
Study Locations (20)
California
- - Coronado
- - La Jolla
- - Los Angeles
- - San Francisco
Florida
- - Bradenton
- - Gainesville
- - Miami
Massachusetts
- - Boston
- - Worcester
Alabama
- - Birmingham
Colorado
- - Aurora
Georgia
- - Atlanta
Indiana
- - Indianapolis
Maryland
- - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 663 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00703118 record still lists
NCT00703118 is an interventional study that assigns participants to a tested intervention. The registered 663 participants enrollment target is mid-sized for trials with a published cap, above the 351-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (89% higher).
The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00703118 names 20 study sites across 14 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00703118 about?
NCT00703118 is a clinical study titled "A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment". The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.
What is the current status of trial NCT00703118?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 663 participants. The study started on 2008-10. Estimated completion is 2010-07.
What conditions does trial NCT00703118 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic.
What interventions are being tested in trial NCT00703118?
The interventions under investigation include: Placebo (DRUG), Ribavirin (DRUG), Telaprevir (DRUG), Peg-IFN-alfa-2a (DRUG).
Who is sponsoring clinical trial NCT00703118?
This trial is sponsored by Tibotec BVBA, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00703118 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C, Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00703118's enrollment target sits among peer trials
663 2nd of 26 the highest of 26 other Hepatitis C, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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