NIDDM and IR in Combination Therapy for CHC

NCT00687999 | Completed DMC

• 1 other identifier: KMUH-IRB-940055
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The influence of insulin sensitivity and glucose tolerance on the effects of antiviral therapy for HCV remains unclear. The aim of the present study was (1) To elucidate the clinical and virological factors associated with sustained viral response in patients with combination therapy with PEG-IFN and ribavirin. (2) To clarify the influence of diabetes mellitus (DM), impaired glucose tolerance test (IGT) and insulin resistance (IR) on the HCV response to combination therapy with PEG-IFN and ribavirin. (3) To test the influence of combination therapy on HOMA IR

Conditions

Chronic Hepatitis C; Insulin Resistance

Keywords

Chronic hepatitis C; diabetes; Insulin resistance; combination therapy

Outcome Measures

Primary Outcomes (1)

• Sustained virological response (SVR) rate, HCV RNA seronegative by PCR throughout 24-week off-treatment period; biochemical, virological and histological characteristics of CHC patients; HOMA-IR change after combination therapy

  18 months

Study Arms (1)

1

OTHER

Drug: pegylated interferon alpha and ribavirin

Interventions

pegylated interferon alpha and ribavirin DRUG

standard pegylated interferon alpha and ribavirin

Also known as: PEG-IFN-alpha

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic hepatitis C patients with positive anti-HCV for more than 6 months and HCV RNA
• No overt hepatic failure or decompensated liver cirrhosis (Child-Pugh class B or C) or hepatocellular carcinoma.

You may not qualify if:

• Positive for hepatitis B surface antigen (HBsAg)or with concomitant human immunodeficiency virus infection
• With other types of hepatitis including autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, Wilson's disease, alpha 1-antitrypsin deficiency
• Current or past history of alcohol abuse (80 mL ethanol per day)

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Related Publications (6)

• Mason AL, Lau JY, Hoang N, Qian K, Alexander GJ, Xu L, Guo L, Jacob S, Regenstein FG, Zimmerman R, Everhart JE, Wasserfall C, Maclaren NK, Perrillo RP. Association of diabetes mellitus and chronic hepatitis C virus infection. Hepatology. 1999 Feb;29(2):328-33. doi: 10.1002/hep.510290235.

  PMID: 9918906 BACKGROUND

• Shintani Y, Fujie H, Miyoshi H, Tsutsumi T, Tsukamoto K, Kimura S, Moriya K, Koike K. Hepatitis C virus infection and diabetes: direct involvement of the virus in the development of insulin resistance. Gastroenterology. 2004 Mar;126(3):840-8. doi: 10.1053/j.gastro.2003.11.056.

  PMID: 14988838 BACKGROUND

• Lecube A, Hernandez C, Simo R, Esteban JI, Genesca J. Glucose abnormalities are an independent risk factor for nonresponse to antiviral treatment in chronic hepatitis C. Am J Gastroenterol. 2007 Oct;102(10):2189-95. doi: 10.1111/j.1572-0241.2007.01402.x. Epub 2007 Jul 7.

  PMID: 17617205 BACKGROUND

• Lee SD, Yu ML, Cheng PN, Lai MY, Chao YC, Hwang SJ, Chang WY, Chang TT, Hsieh TY, Liu CJ, Chen DS. Comparison of a 6-month course peginterferon alpha-2b plus ribavirin and interferon alpha-2b plus ribavirin in treating Chinese patients with chronic hepatitis C in Taiwan. J Viral Hepat. 2005 May;12(3):283-91. doi: 10.1111/j.1365-2893.2005.00590.x.

  PMID: 15850469 BACKGROUND

• Romero-Gomez M, Del Mar Viloria M, Andrade RJ, Salmeron J, Diago M, Fernandez-Rodriguez CM, Corpas R, Cruz M, Grande L, Vazquez L, Munoz-De-Rueda P, Lopez-Serrano P, Gila A, Gutierrez ML, Perez C, Ruiz-Extremera A, Suarez E, Castillo J. Insulin resistance impairs sustained response rate to peginterferon plus ribavirin in chronic hepatitis C patients. Gastroenterology. 2005 Mar;128(3):636-41. doi: 10.1053/j.gastro.2004.12.049.

  PMID: 15765399 BACKGROUND

• D'Souza R, Sabin CA, Foster GR. Insulin resistance plays a significant role in liver fibrosis in chronic hepatitis C and in the response to antiviral therapy. Am J Gastroenterol. 2005 Jul;100(7):1509-15. doi: 10.1111/j.1572-0241.2005.41403.x.

  PMID: 15984973 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic; Insulin Resistance; Diabetes Mellitus

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Wan-Long Chuang, MD, PhD.

  Department of Internal Medicine, Kaohsiung Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: December 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 6, 2009

Record last verified: 2008-05

Locations

TW (1)