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NCT00882193 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers
A Early Phase 1 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT00882193 is a Early Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 2 participants.
The verdict
NCT00882193, a Early Phase 1 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is a non-randomized, open-label study examining the safety and efficacy of betaine in addition to standard anti-viral therapy in genotype 1 hepatitis C non-responders or relapsers to previous pegylated interferon plus ribavirin. Betaine (20 gm/day) in 2 divided doses will be added to Peginterferon alpha 2a (180 mcg) plus weight-based Ribavirin (1000 or 1200 mg/day, for body weight \< or \> 75 kg, respectively, for 48 weeks. Patients must be diagnosed with chronic hepatitis C, genotype I, and have undergone therapy for hepatitis C with pegylated interferon plus ribavirin. Subjects will be followed for safety, tolerability, hepatitis C viral response and the effect on interferon gene signaling in peripheral blood mononuclear cells during therapy.
Interventions
- DRUG Ribavirin
- DRUG Betaine
- DRUG Peginterferon alpha 2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-05-01 |
| Est. Completion | 2011-01-12 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00882193
The ClinicalTrials.gov registry entry for NCT00882193 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT00882193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00882193 about?
NCT00882193 is a clinical study titled "Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers". This is a non-randomized, open-label study examining the safety and efficacy of betaine in addition to standard anti-viral therapy in genotype 1 hepatitis C non-responders or relapsers to previous pegylated interferon plus ribavirin. Betaine (20 gm/day) in 2 divided doses will be added to Peginterfe...
What is the current status of trial NCT00882193?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2009-05-01. Estimated completion is 2011-01-12.
What interventions are being tested in trial NCT00882193?
The interventions under investigation include: Ribavirin (DRUG), Betaine (DRUG), Peginterferon alpha 2a (DRUG).
Who is sponsoring clinical trial NCT00882193?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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