Suspended

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

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What is being tested

metformin

+ pegylated-IFN

+ ribavirin

Drug
Who is being recruted

Blood-Borne Infections+19

+ Chronic Disease

+ Communicable Diseases

From 20 to 80 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorKaohsiung Veterans General Hospital.
Study ContactWei-Lun Tsai, MDMore contacts
Last updated: August 14, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01664845
Principal SponsorKaohsiung Veterans General Hospital.
Study ContactWei-Lun Tsai, MDMore contacts
Last updated: August 14, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesHepatitisHepatitis, ChronicHepatitis, Viral, HumanHyperinsulinismInfectionsLiver DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesFlaviviridae InfectionsDisease AttributesGlucose Metabolism DisordersHepatitis CInsulin ResistanceHepatitis C, Chronic

Criteria

3 inclusion criteria required to participate
Compensated liver
HCV RNA (+) and ALT > 40 U/L
HOMA-IR > 2
11 exclusion criteria prevent from participating
Alcohol use > 20 gm per day
Cr > 2.5 mg/dl
Diabetes
HBV/HIV co-infection
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
metformin,pegylated-IFN and ribavirin

Group II

Placebo
pegylated -IFN and ribavirin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Kaohsiung Veterans General Hospital

Kaohsiung, TaiwanOpen Kaohsiung Veterans General Hospital in Google Maps
SuspendedOne Study Center