Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

Insulin Resistance Clinical Trial

Official title:

Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01664845
• Other study ID #: VGHKS12-CT3-16
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 10, 2012
• Last updated: August 13, 2012
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2012
• Source: Kaohsiung Veterans General Hospital.
• Contact: Wei-Lun Tsai, MD
• Phone: 886-7-3422121
• Email: tsaiwl[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic hepatitis C virus (HCV).

Description:

Current standard of treatment for HCV with pegylated interferon(Peg-IFN)-alpha and ribavirin can achieve sustained virological response (SVR) in only 60-90% of patients. Insulin resistance is an important factor of non-response to combination therapy. Metformin is a insulin sensitizer and can effectively reduce insulin resistance. The aim of the study is to investigate the treatment response of metformin, Peg-IFN and ribavirin combination therapy for chronic HCV.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• HCV RNA (+) and ALT > 40 U/L

• Compensated liver

• HOMA-IR > 2

Exclusion Criteria:

• neutrophil <1500/mm3

• male: Hb < 13 g/dl, female: Hb < 12 g/dl

• platelet < 80,000 /mm3

• Cr > 2.5 mg/dl

• Alcohol use > 20 gm per day

• uncontrolled depression, thyroid disease, autoimmune disease

• Pregnancy

• Hepatocellular carcinoma

• allergy to interferon or ribavirin

• Diabetes

• HBV/HIV co-infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Insulin Resistance

Intervention

Drug:
• metformin
metformin 500mg tid
• pegylated-IFN
pegasys 180 mcg qw
• ribavirin
ribavirin 800-1200 mg qd according to BW

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	RVR	HCV RNA At 4 weeks	HCV RNA At 4 weeks	Yes
Primary	sustained virological response	HCV RNA negative 24 weeks after treatment is stopped	24 weeks after treatment is stopped	No
Secondary	change of HOMA-IR	Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment	Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment	No