Overview

The Effects of Oral Hypoglycemic Agents on Chronic Hepatitis C Patients Receiving Peg-Intron Plus Ribavirin

Status:
Unknown status

Trial end date:
2012-12-01

Target enrollment:
0

Participant gender:
All

Summary

Pegylated interferon in combination with ribavirin is the current standard treatment of chronic hepatitis C virus infection, but is expensive and has several adverse effects. To modify this standard treatment by optimizing its therapeutic effect and decreasing its adverse events are important. Recent studies have identified a close link between metabolic profiles, insulin resistance and Hepatitis C Virus (HCV) infection. Several pilot studies in western world have have found beneficial effects of oral hypoglycemic agents on chronic Hepatitis C (CHC) genotype 1 infected patients. Whether this concept still holds true in Taiwanese people remains unknown. The objective of this clinical trial is to evaluate the effect of oral hypoglycemic agents (daily for 4 weeks of run-in period and 8 weeks of combination treatment) on CHC genotype 1 infected Taiwanese patients receiving 48 weeks of Peg-IFN plus ribavirin (RBA), and the enrolled subjects will be randomized into 4 treatment groups (including Acarbose, Metformin, Pioglitazone and standard care control groups). During the trial and 24 weeks after the end of treatment, serial serum HCV RNA, alanine aminotransferase (ALT) levels, and other clinical data will be evaluated to determine the therapeutic response and adverse events of the CHC patients.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Taiwan University Hospital

Collaborators:

Merck Sharp & Dohme Corp.
Schering-Plough

Treatments:

Acarbose
Hypoglycemic Agents
Interferon-alpha
Metformin
Peginterferon alfa-2b
Pioglitazone
Ribavirin

Criteria

Inclusion Criteria:

1. Treatment naïve

2. Age old than 18 years old

3. Anti-HCV positive > 6 months

4. Detectable serum quantitative HCV-RNA

5. HCV genotype 1

6. Serum alanine aminotransferase levels above the upper limit of normal with 6 months of
enrollment

7. Pre-treatment HOMA-IR ≧ 2.0. (HOMA-IR = fasting insulin (mU/L) x fasting glucose
(mg/dL) x 0.05551/22.5)

Exclusion Criteria:

1. Anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for
women)

2. Neutropenia (neutrophil count <1,500 per cubic milliliter)

3. Thrombocytopenia (platelet <90,000 per cubic milliliter)

4. Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

5. Chronic alcohol abuse (daily consumption > 20 gram per day in male and >10gram per day
in female).

6. Diabetes Mellitus history or under oral hypoglycemic agents therapy Liver cirrhosis

7. Serum creatinine level more than 1.5 times the upper limit of normal Autoimmune liver
disease

8. Neoplastic disease

9. An organ transplant

10. Immunosuppressive therapy

11. Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases,
psychiatric diseases, neurological diseases, diabetes mellitus

12. Evidence of drug abuse

13. Unwilling to have contraception