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Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
NCT00006164 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006164
The ClinicalTrials.gov registry entry for NCT00006164 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,050 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 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00006164 reports 11 study locations spanning 9 distinct geographic areas — top geographies include California, Massachusetts, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Fibrosis, Liver, Hepatic Cirrhosis, Chronic Hepatitis c. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00006164?
The interventions under investigation include: Peginterferon alfa-2a (DRUG), Peginterferon alfa-2a + Ribavirin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00006164?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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