Hepatitis C Clinical Trial
Official title:
The Impact of Peginterferon Alpha-2a Maintenance Therapy on Portal Hypertension in Patients With Chronic Hepatitis C Virus Infection and Advanced Fibrosis and Cirrhosis Enrolled in the HALT-C Trial
Verified date | March 2017 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of this study is to determine if peginterferon alpha-2a maintenance therapy (90 mcg/week) will lower portal pressure in patients with hepatitis C virus infections and advanced fibrosis or cirrhosis.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Completion of HALT-C Trial, in either treatment or non-treatment arm Exclusion Criteria: - Non-completion of HALT-C Trial - Patients who do not wish to be treated with peginterferon after the first portal pressure measurement - Hepatocellular Carcinoma - Underlying autoimmune disorder - Currently being treated with immune suppressive agent - Illicit drug use - Alcohol use of more than 6 grams per day - Advanced cardiopulmonary disease - Uncontrolled diabetes mellitus - Patients who, in the opinion of the investigator, should not participate in this trial |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | Roche Pharma AG |
United States,
Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. — View Citation
Charlton M. Hepatitis C infection in liver transplantation. Am J Transplant. 2001 Sep;1(3):197-203. Review. — View Citation
Garcia N Jr, Sanyal AJ. Portal hypertension. Clin Liver Dis. 2001 May;5(2):509-40. Review. — View Citation
Imai Y, Kawata S, Tamura S, Yabuuchi I, Noda S, Inada M, Maeda Y, Shirai Y, Fukuzaki T, Kaji I, Ishikawa H, Matsuda Y, Nishikawa M, Seki K, Matsuzawa Y. Relation of interferon therapy and hepatocellular carcinoma in patients with chronic hepatitis C. Osaka Hepatocellular Carcinoma Prevention Study Group. Ann Intern Med. 1998 Jul 15;129(2):94-9. — View Citation
Lee WM, Dienstag JL, Lindsay KL, Lok AS, Bonkovsky HL, Shiffman ML, Everson GT, Di Bisceglie AM, Morgan TR, Ghany MG, Morishima C, Wright EC, Everhart JE; HALT-C Trial Group.. Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders. Control Clin Trials. 2004 Oct;25(5):472-92. — View Citation
Poynard T, McHutchison J, Manns M, Trepo C, Lindsay K, Goodman Z, Ling MH, Albrecht J. Impact of pegylated interferon alfa-2b and ribavirin on liver fibrosis in patients with chronic hepatitis C. Gastroenterology. 2002 May;122(5):1303-13. — View Citation
Shiffman ML, Hofmann CM, Contos MJ, Luketic VA, Sanyal AJ, Sterling RK, Ferreira-Gonzalez A, Mills AS, Garret C. A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia. Gastroenterology. 1999 Nov;117(5):1164-72. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in portal pressure after 6 moths of treatment with peginterferon alfa-2a will be calculated by comparing portal pressure at the end of HALT-C to values obtained after 6 months of peginterferon. |
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