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NCT00475176 · ClinicalTrials.gov registry record · Phase 2
S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00475176: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00475176 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00475176, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will examine the effectiveness of S-adenosyl methionine (SAMe) in combination with peginterferon and ribavirin for treating hepatitis C virus. One out of three patients with hepatitis C develops cirrhosis of the liver, which can lead to liver failure or liver cancer. SAMe is a nutritional supplement that is made naturally in all cells of the body and acts to improve how the body handles stress. In laboratory experiments with liver cells, SAMe decreases the injury caused by liver toxins and improves the ability of interferon to block hepatitis C virus. Patients 18 years of age and older with hepatitis C infection who did not respond successfully to prior treatment with interferon and ribavirin or peginterferon and ribavirin may be eligible for this study. Participants receive the following treatment: * Peginterferon (given by injection) and ribavirin (taken by mouth) for 2 weeks * Washout period (no medications) for 4 weeks * SAMe (taken by mouth) for 2 weeks * Peginterferon, ribavirin and SAMe for 12-48 weeks, depending on patient response to treatment. Participants have a thorough physical evaluation before beginning treatment and again at the study's end. After starting treatment, patients return for clinic visits and blood tests weekly for the first several weeks, then less frequently (at 2-week, then 4-week and 8-week intervals until up to 72 weeks) to monitor symptoms, drug side effects, hepatitis C virus levels, liver enzyme levels and immune responses to hepatitis C. ...
Primary Outcome
Improvement of slopes of decline in hepatitis C virus Ribonucleic acid in second course compared with first course in days 7 to 14 of therapy
Interventions
- DRUG Ribavirin
- DRUG Peginterferon alfa-2a
- DRUG S-adenosyl methionine for Chronic Liver Disease
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00475176 record still lists
NCT00475176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT00475176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00475176 about?
NCT00475176 is a clinical study titled "S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C". This study will examine the effectiveness of S-adenosyl methionine (SAMe) in combination with peginterferon and ribavirin for treating hepatitis C virus. One out of three patients with hepatitis C develops cirrhosis of the liver, which can lead to liver failure or liver cancer. SAMe is a nutritional...
What is the current status of trial NCT00475176?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2007-05. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00475176?
The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG), S-adenosyl methionine for Chronic Liver Disease (DRUG).
Who is sponsoring clinical trial NCT00475176?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00475176's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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