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NCT00001854 · ClinicalTrials.gov registry record · Phase 4
Long-Term Therapy With Ribavirin for Chronic Hepatitis C
A Phase 4 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT00001854 is a Phase 4 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 50 participants.
The verdict
NCT00001854, a Phase 4 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
Chronic hepatitis C is a disease of the liver caused by the hepatitis C virus. The disease can be serious and even fatal. Approximately 25% of patients with chronic hepatitis C will develop cirrhosis and some of these patients will develop cancer of the liver or liver failure. Presently the disease is treated with a combination of alpha interferon or peginterferon (antiviral and immune stimulating drugs) and ribavirin (an antiviral drug). Alpha interferon is given by injection three times a week whereas peginterferon is given by injection only once a week. Ribavirin is given as a tablet by mouth twice a day. The combination therapy is given for 6 to months. About half of the patients given these medications will receive a lasting benefit and many patients do not respond well to the combination therapy. This study will select up to 50 patients will chronic hepatitis C who have not responded to combination therapy or who could not stand the side effects associated with interferon or peginterferon therapy. These subjects will be evaluated and undergo liver biopsy to determine their present liver condition. If selected as subjects they will be started on single drug therapy with ribavirin. The drug will be given orally twice a day at a dose based on the patient's body weight. The patients will be followed on an out-patient basis. They will we asked to return for regular check-ups and blood tests every 2 to 8 weeks for the duration of the study. After 6 months, the medication will be stopped or adjusted based on the results of the subject's blood tests (liver enzymes). A response is considered if a decrease of 50% or more of the initial liver enzyme (alanine aminotransferase, ALT) is noted. A complete response will be considered if liver enzymes return to normal levels. Therapy will be discontinued after 6 months if patients do not respond. However, patients that respond to the single drug therapy will continue to receive the medication at a decreased dose. The patie
Interventions
- DRUG Ribavirin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 1999-02-12 |
| Est. Completion | 2008-01-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001854
The ClinicalTrials.gov registry entry for NCT00001854 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 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 1 intervention - of which Ribavirin is the first listed.
NCT00001854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001854 about?
NCT00001854 is a clinical study titled "Long-Term Therapy With Ribavirin for Chronic Hepatitis C". Chronic hepatitis C is a disease of the liver caused by the hepatitis C virus. The disease can be serious and even fatal. Approximately 25% of patients with chronic hepatitis C will develop cirrhosis and some of these patients will develop cancer of the liver or liver failure. Presently the disease...
What is the current status of trial NCT00001854?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 1999-02-12. Estimated completion is 2008-01-15.
What interventions are being tested in trial NCT00001854?
The interventions under investigation include: Ribavirin (DRUG).
Who is sponsoring clinical trial NCT00001854?
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.
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