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NCT00006164 · ClinicalTrials.gov registry record · Phase 3
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
A Phase 3 study of Cirrhosis, Liver and Chronic Hepatitis C, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,050
- Enrollment target
- 11
- Study locations
NCT00006164: Completed Phase 3 study of Cirrhosis, Liver and Chronic Hepatitis C, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00006164 is a Phase 3 study of Cirrhosis, Liver and Chronic Hepatitis C that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 1,050 participants, above the 211-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (398% higher). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006164, a Phase 3 study of Cirrhosis, Liver and Chronic Hepatitis C, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,050 participants
- Enrollment target
- 11
- Study locations
Study Summary
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months. Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits. The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial. The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.
Primary Outcome
Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fi
Conditions Studied
Interventions
- DRUG Peginterferon alfa-2a
- DRUG Peginterferon alfa-2a + Ribavirin
Study Locations (11)
California
- University of California-Irvine/VA Medical Center-Long Beach - Long Beach
- USC School of Medicine - Los Angeles
Massachusetts
- Massachusetts General Hospital - Boston
- UMass Memorial HealthCare, University Campus - Worcester
Colorado
- UCHSC (University of Colorado) - Denver
Connecticut
- University of Connecticut Health Center - Farmington
Maryland
- Lds, Niddk, Nih - Bethesda
Michigan
- University of Michigan - Ann Arbor
Missouri
- Saint Louis University - St Louis
Texas
- University of Texas Southwestern - Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,050 participants |
| Start Date | 2000-06 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00006164 record still lists
NCT00006164 is an interventional study that assigns participants to a tested intervention. Its 1,050 participants enrollment target places it among the larger protocols in the corpus, above the 211-participant average among 34 other Cirrhosis, Liver trials with a reported enrollment target (398% higher).
The record links to 4 conditions, with Cirrhosis, Liver appearing as the primary indexed condition, and to 2 interventions - of which Peginterferon alfa-2a is the first listed.
NCT00006164 lists 11 locations in 9 states (California, Massachusetts, Colorado).
Frequently Asked Questions
What is clinical trial NCT00006164 about?
NCT00006164 is a clinical study titled "Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment". The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treat...
What is the current status of trial NCT00006164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,050 participants. The study started on 2000-06. Estimated completion is 2009-10.
What conditions does trial NCT00006164 study?
This clinical trial studies the following conditions: Cirrhosis, Liver, Chronic Hepatitis C, Fibrosis, Liver, Hepatic Cirrhosis.
What interventions are being tested in trial NCT00006164?
The interventions under investigation include: Peginterferon alfa-2a (DRUG), Peginterferon alfa-2a + Ribavirin (DRUG).
Who is sponsoring clinical trial NCT00006164?
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.
Where is trial NCT00006164 being conducted?
This trial has 11 study locations across California, Colorado, Connecticut, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00006164's enrollment target sits among peer trials
1,050 2nd of 34 the highest of 34 other Cirrhosis, Liver trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis, Liver 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.
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