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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: Clinical Trial Early Phase 1 study, sponsored by University of Nebraska.
NCT00882193 is a Early Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To examine the safety and efficacy of betaine when combined with standard antiviral therapy in previously treated subjects with chronic hepatitis c genotype 1
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 |
Why NCT00882193 stopped before completion
NCT00882193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT00882193 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00882193's enrollment target sits among peer trials
2 1973rd of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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