Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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. ...
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00475176
The ClinicalTrials.gov registry entry for NCT00475176 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT00475176 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.