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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 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 35 participants.
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.
Interventions
- DRUG ribavirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01097395
The ClinicalTrials.gov registry entry for NCT01097395 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ribavirin is the first listed.
NCT01097395 reports 0 study locations.
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.
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