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NCT01097395 · ClinicalTrials.gov registry record · Phase 4
Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT01097395: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT01097395 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01097395, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposures and if it appears safe and effective compared with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants with genotype 1 disease will be randomized to receive concentration-guided or standard weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided through the study.
Primary Outcome
Demonstrate that concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposure with reduced variability in the steady-state area-under-the-concentration-time curve (AUC0-12) compared with standard weight-based ribavirin dosing
Interventions
- DRUG ribavirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
What the finished NCT01097395 record still lists
NCT01097395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which ribavirin is the first listed.
NCT01097395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01097395 about?
NCT01097395 is a clinical study titled "Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection". The purpose of this study is to determine if concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposures and if it appears safe and effective compared with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants with genotype 1 disease wi...
What is the current status of trial NCT01097395?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2010-02. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01097395?
The interventions under investigation include: ribavirin (DRUG).
Who is sponsoring clinical trial NCT01097395?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01097395's enrollment target sits among peer trials
35 1506th of 2000 higher than 481 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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