Protocol Number: 00-DK-0186

Title:

The Hep C Antiviral Long-Term Tx Against Cirrhosis (HALT-C) Trial: A Randomized Controlled Trial to Evaluate the Safety & Efficacy of Long-Term Peginterferon Alpha2A for Tx of Chronic Hep C in Patients Who Failed to Respond to Previous Interferon Therapy

Number:

00-DK-0186

Summary:

This study will test whether long-term antiviral therapy with interferon can prevent liver disease from progressing in patients with chronic hepatitis C infection-a long-lasting viral infection affecting the liver. About 1,200 patients in 10 centers across the United States will be enrolled in this study to determine the best treatment for patients with advanced scarring of the liver who do not respond to short-term interferon therapy. These patients are at the greatest risk of going developing liver cirrhosis, liver failure or liver cancer.

Patient 18 years of age or older with hepatitis C and advanced scarring who have not responded to previous interferon treatment, either with or without ribavirin, may be eligible for this study. Candidates will be screened with a medical history and physical examination, questionnaires on drug and alcohol use, mood and quality of life, blood tests, liver ultrasound and, if needed, a liver biopsy (removal of a small sample of liver tissue for microscopic evaluation).

All patients enrolled in the study will receive interferon injections under the skin once a week and ribavirin by mouth twice a day for 24 weeks. At periodically scheduled clinic visits, patients will fill out a questionnaire about symptoms and have blood tests and vital signs taken. They will have a physical exam and gastrointestinal and liver exam every 12 weeks and will complete questionnaires on general health and mood at weeks 12 and 20. After 24 weeks, patients will be examined for evidence of virus in their blood and will be divided into responders (no virus detected in the blood) and non-responders (virus is detected in the blood).

Responders will continue the same treatment for another 24 weeks. At the end of treatment, they will be followed periodically for another 24 weeks with undergo physical examinations, gastrointestinal and liver exams, and blood collection to assess disease progress and side effects of treatment. A small portion of blood will be stored for future testing to identify factors that affect the progress of liver disease and development of liver cancer. This may include genetic testing.

Non-responders will be randomly divided into two groups for the next phase of the study-long-term maintenance therapy-that will continue for an additional 3 1/2 years. One group will receive interferon alone; the other will receive no treatment. Every 3 months during treatment and 6 months after maintenance the maintenance phase ends, patients will undergo the following procedures:

1. Physical examination and gastrointestinal and liver exam (every visit).

2. Blood sample collection to monitor disease progress and treatment side effects (every visit). A small portion of blood will be stored for future testing to identify factors that affect the progress of liver disease and development of liver cancer. These may include genetic testing.

3. Questionnaires about general health and daily activities (every 6 months).

4. Ultrasound examinations of the liver (yearly).

5. Liver biopsy (2 years and 4 years after the start of the first phase of the study).

6. Endoscopy (between week 22 and week 26 and at 4 years). This test uses a thin flexible tube with a light at the tip to examine the esophagus (food pipe) for abnormal veins called varices, which can rupture and bleed. If varices are found, another examination will be done at 24 months.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Prevention

Hepatocellular Carcinoma

Complications

Natural History

Fibrosis

Recruitment Keyword(s):

Hepatitis C

Condition(s):

Hepatitis C

Liver Cirrhosis

Investigational Drug(s):

Pegylated Interferon

Investigational Device(s):

None

Interventions:

Drug: Pegylated Interferon

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Diseases

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Epidemiology of hepatitis c

Epidemiology of the hepatitis c virus

Hepatitis c: the clinical spectrum of disease

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009