Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment (HALT-C)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Hepatic Cirrhosis; Fibrosis, Liver; Cirrhosis, Liver; Chronic Hepatitis c

Treatments: Drug: Peginterferon alfa-2a; Drug: Peginterferon alfa-2a + Ribavirin

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00006164

N01-DK-9-2325 (Other Grant/Funding Number)

N01-DK-9-2320 (Other Grant/Funding Number)

N01-DK-9-2327 (Other Grant/Funding Number)

HALT C

N01-DK-9-2322 (Other Grant/Funding Number)

N01-DK-9-2328 (Other Grant/Funding Number)

N01-DK-9-2318 (Other Grant/Funding Number)

N01-DK-9-2321 (Other Grant/Funding Number)

N01-DK-9-2324 (Other Grant/Funding Number)

N01-DK-9-2323 (Other Grant/Funding Number)

N01-DK-9-2326 (Other Grant/Funding Number)

N01-DK-9-2319 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 1,050 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,050 participants in 2 patient groups

1

Experimental group

Description:

Peg-interferon alfa-2a 90 mcg/week

Treatment:

Drug: Peginterferon alfa-2a

Drug: Peginterferon alfa-2a + Ribavirin

2

Active Comparator group

Description:

Standard of care followup

Treatment:

Drug: Peginterferon alfa-2a + Ribavirin