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

NCT01025765 | Unknown Phase 4

• 1 other identifier: 200905056M
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response

  at the end of 24 weeks post-treatment follow-up

Secondary Outcomes (1)

• serum ALT normalization, and histologic improvement

  at the end of treatment and 24 weeks after the end of treatment

Study Arms (4)

Standard care of CHC

NO INTERVENTION

From week 5, all the patients will receive Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; \< 75 kg, 1000mg) for 48 weeks.

Pioglitazone

EXPERIMENTAL

From week 5, all the patients will receive Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; \< 75 kg, 1000mg) for 48 weeks.

Drug: Pioglitazone

Acarbose

EXPERIMENTAL

From week 5, all the patients will receive Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; \< 75 kg, 1000mg) for 48 weeks.

Drug: Acarbose

Metformin

EXPERIMENTAL

From week 5, all the patients will receive Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; \< 75 kg, 1000mg) for 48 weeks.

Drug: Metformin

Interventions

Pioglitazone DRUG

Pioglitazone(30mg qd) for 4 weeks of run-in period and 8 weeks of combination treatment with Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; \< 75 kg, 1000mg).

Pioglitazone

Acarbose DRUG

Acarbose (50 mg/per meal) for 4 weeks of run-in period and 8 weeks of combination treatment with Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; \< 75 kg, 1000mg).

Acarbose

Metformin DRUG

Metformin (500 mg tid) 4 weeks of run-in period and 8 weeks of combination treatment with Peginterferon alfa-2b (1.5/μg per kg) per week plus Ribavirin 1000-1200 mg/day (≥ 75 kg, 1200 mg; \< 75 kg, 1000mg). From week 13, all the subjects will receive pegylated interferon alfa plus ribavirin for 40 weeks.

Metformin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment naïve
• Age old than 18 years old
• Anti-HCV positive \> 6 months
• Detectable serum quantitative HCV-RNA
• HCV genotype 1
• Serum alanine aminotransferase levels above the upper limit of normal with 6 months of enrollment
• Pre-treatment HOMA-IR ≧ 2.0. (HOMA-IR = fasting insulin (mU/L) x fasting glucose (mg/dL) x 0.05551/22.5)

You may not qualify if:

• Anemia (hemoglobin \< 13 gram per deciliter for men and \< 12 gram per deciliter for women)
• Neutropenia (neutrophil count \<1,500 per cubic milliliter)
• Thrombocytopenia (platelet \<90,000 per cubic milliliter)
• Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Chronic alcohol abuse (daily consumption \> 20 gram per day in male and \>10gram per day in female).
• Diabetes Mellitus history or under oral hypoglycemic agents therapy Liver cirrhosis
• Serum creatinine level more than 1.5 times the upper limit of normal Autoimmune liver disease
• Neoplastic disease
• An organ transplant
• Immunosuppressive therapy
• Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
• Evidence of drug abuse
• Unwilling to have contraception

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Schering-Plough: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

National Taiwan University Hospital Department of Internal Medicine,

Taipei, Taiwan, 10002, Taiwan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Pioglitazone; Acarbose; Metformin

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Biguanides; Guanidines; Amidines

Study Officials

• Jia-Horng Kao, M.D., PhD.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jia-Horng Kao, National Taiwan University Hospital

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

TW (1)