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

NCT ID: NCT01664845

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis c Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin, pegylated-IFN, ribavirin

metformin,pegylated-IFN and ribavirin

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

metformin 500mg tid

pegylated-IFN

Intervention Type DRUG

pegasys 180 mcg qw

ribavirin

Intervention Type DRUG

ribavirin 800-1200 mg qd according to BW

Pegylated-IFN and ribavirin

pegylated -IFN and ribavirin

Group Type PLACEBO_COMPARATOR

pegylated-IFN

Intervention Type DRUG

pegasys 180 mcg qw

ribavirin

Intervention Type DRUG

ribavirin 800-1200 mg qd according to BW

Interventions

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metformin

metformin 500mg tid

Intervention Type DRUG

pegylated-IFN

pegasys 180 mcg qw

Intervention Type DRUG

ribavirin

ribavirin 800-1200 mg qd according to BW

Intervention Type DRUG

Other Intervention Names

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glucophage pegasys

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Wei-Lun Tsai

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei-Lun Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Kaohsoung Veterans General Hospital

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wei-Lun Tsai, MD

Role: CONTACT

886-7-3422121 ext. 2075

Facility Contacts

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Wei-Lun Tsai, MD

Role: primary

886-7-3422121 ext. 2075

Other Identifiers

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VGHKS12-CT3-16

Identifier Type: -

Identifier Source: org_study_id

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