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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664845

Enrollment

120

Registered

2012-08-14

Start date

2012-08-31

Completion date

2014-08-31

Last updated

2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis c, Insulin Resistance

Keywords

hepatitis c, metformin, pegylated interferon

Brief 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).

Detailed 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.

Interventions

DRUGmetformin

metformin 500mg tid

DRUGpegylated-IFN

pegasys 180 mcg qw

DRUGribavirin

ribavirin 800-1200 mg qd according to BW

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
sustained virological response	24 weeks after treatment is stopped	HCV RNA negative 24 weeks after treatment is stopped

Secondary

Measure	Time frame	Description
change of HOMA-IR	Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment	Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment

Other

Measure	Time frame	Description
RVR	HCV RNA At 4 weeks	HCV RNA At 4 weeks

Countries

Taiwan

Contacts

Primary ContactWei-Lun Tsai, MD

tsaiwl@yahoo.com.tw886-7-3422121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026