Phase 3
N=1,050
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
Chronic Hepatitis c · Cirrhosis, Liver · Fibrosis, Liver · Hepatic Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT00006164 ↗Enrolled (actual)
1,050
Serious AEs
31.4%
Results posted
Sep 2009
Primary outcome: Primary: Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points — 157; 157 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Peginterferon alfa-2a + Ribavirin (Drug); Peginterferon alfa-2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points |
157; 157 | — |
| PRIMARY Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies |
71; 81 | — |
| PRIMARY Death From Any Cause |
31; 22 | — |
| PRIMARY Development of Hepatocellular Carcinoma (HCC) |
13; 16 | — |
| PRIMARY Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits |
57; 52 | — |
| PRIMARY Variceal Hemorrhage |
5; 11 | — |
| PRIMARY Ascites |
32; 27 | — |
| PRIMARY Spontaneous Bacterial Peritonitis |
3; 3 | — |
| PRIMARY Hepatic Encephalopathy |
15; 22 | — |
| SECONDARY Serious Adverse Events |
175; 155 | — |
| SECONDARY Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy. |
-0.07; -0.09; 0.12; 0.12 | — |
| SECONDARY Presumed Hepatocellular Carcinoma (HCC) |
10; 9 | — |
| SECONDARY SF-36 Vitality Summary Score |
-6.05; -1.61; -6.40; -3.24; -5.68; -2.97 | — |
| SECONDARY SF-36 Physical Function Summary Score |
-1.64; -0.97; -2.41; -1.63; -1.99; -1.68 | — |
| SECONDARY SF-36 Mental Health Summary Score |
-2.62; -1.08; -2.22; -1.67; -2.65; -2.15 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age at entry at least 18 years.
- Positive for Hepatitis C.
- Previous treatment with any interferon or interferon and ribavirin for at least 3 months.
- Documented non-response to treatment with interferon.
- A liver biopsy demonstrating significant liver scarring.
Exclusion Criteria
- No other liver disease.
- No unstable major medical diseases or conditions.
- No major complications of cirrhosis.
- No recent abuse of alcohol or illicit drugs.
Data sourced from ClinicalTrials.gov (NCT00006164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.