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

Overview[ - collapse ][ - ]

Purpose 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).
ConditionChronic Hepatitis c
Insulin Resistance
InterventionDrug: metformin
Drug: pegylated-IFN
Drug: ribavirin
PhasePhase 2/Phase 3
SponsorKaohsiung Veterans General Hospital.
Responsible PartyKaohsiung Veterans General Hospital.
ClinicalTrials.gov IdentifierNCT01664845
First ReceivedAugust 10, 2012
Last UpdatedAugust 13, 2012
Last verifiedAugust 2012

Tracking Information[ + expand ][ + ]

First Received DateAugust 10, 2012
Last Updated DateAugust 13, 2012
Start DateAugust 2012
Estimated Primary Completion DateAugust 2014
Current Primary Outcome Measuressustained virological response [Time Frame: 24 weeks after treatment is stopped] [Designated as safety issue: No]HCV RNA negative 24 weeks after treatment is stopped
Current Secondary Outcome Measureschange of HOMA-IR [Time Frame: Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment] [Designated as safety issue: No]Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment

Descriptive Information[ + expand ][ + ]

Brief TitleEffects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Official TitleEffects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
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.
Study TypeInterventional
Study PhasePhase 2/Phase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Chronic Hepatitis c
  • Insulin Resistance
InterventionDrug: metformin
metformin 500mg tid
Other Names:
glucophageDrug: pegylated-IFN
pegasys 180 mcg qw
Other Names:
pegasysDrug: ribavirin
ribavirin 800-1200 mg qd according to BW
Study Arm (s)
  • Active Comparator: metformin, pegylated-IFN, ribavirin
    metformin,pegylated-IFN and ribavirin
  • Placebo Comparator: Pegylated-IFN and ribavirin
    pegylated -IFN and ribavirin

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment120
Estimated Completion DateAugust 2014
Estimated Primary Completion DateAugust 2014
Eligibility Criteria
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
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsContact: Wei-Lun Tsai, MD
886-7-3422121
tsaiwl@yahoo.com.tw
Location CountriesTaiwan

Administrative Information[ + expand ][ + ]

NCT Number NCT01664845
Other Study ID NumbersVGHKS12-CT3-16
Has Data Monitoring CommitteeNo
Information Provided ByKaohsiung Veterans General Hospital.
Study SponsorKaohsiung Veterans General Hospital.
CollaboratorsNot Provided
Investigators Principal Investigator: Wei-Lun Tsai, MD Department of Gastroenterology, Kaohsoung Veterans General Hospital
Verification DateAugust 2012

Locations[ + expand ][ + ]

Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Contact: Wei-Lun Tsai, MD | 886-7-34221212075 | tsaiwl@yahoo.com.tw
Principal Investigator: Wei-Lun Tsai, MD
Recruiting