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NCT00535847 · ClinicalTrials.gov registry record · Phase 2
A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
A Phase 2 study of Hepatitis C, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
- 20
- Study locations
NCT00535847: Completed Phase 2 study of Hepatitis C, sponsored by Vertex Pharmaceuticals Incorporated.
NCT00535847 is a Phase 2 study of Hepatitis C that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 117 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00535847, a Phase 2 study of Hepatitis C, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
- 20
- Study locations
Study Summary
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
Primary Outcome
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG Telaprevir
- DRUG Pegylated interferon alfa 2a
Study Locations (20)
Florida
- University of Florida - Gainesville
- Borland-Groover Clinic - Jacksonville
- Mayo Clinic Jacksonville - Jacksonville
- University of Miami Center for Liver Diseases - Miami
- - Sarasota
California
- - Los Angeles
- Kaiser Permanente Internal Medicine - San Diego
- - San Francisco
Colorado
- University of Colorado Health Sciences Center - Denver
- South Denver Gastroenterology - Englewood
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- University of Massachusetts Memorial Medical Center - Worcester
Alabama
- - Birmingham
Georgia
- Atlanta Gastroenterology Associates - Atlanta
Illinois
- University of Chicago - Chicago
Indiana
- - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
What the finished NCT00535847 record still lists
NCT00535847 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which Ribavirin is the first listed.
NCT00535847 names 20 study sites across 12 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00535847 about?
NCT00535847 is a clinical study titled "A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy". To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonu...
What is the current status of trial NCT00535847?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2007-10. Estimated completion is 2010-02.
What conditions does trial NCT00535847 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT00535847?
The interventions under investigation include: Ribavirin (DRUG), Telaprevir (DRUG), Pegylated interferon alfa 2a (DRUG).
Who is sponsoring clinical trial NCT00535847?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00535847 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
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 NCT00535847's enrollment target sits among peer trials
117 51st of 106 higher than 56 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
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A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
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Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
COMPLETED · Phase 2
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