Back to resultsEffects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Primary Purpose
Chronic Hepatitis c, Insulin Resistance
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
metformin
pegylated-IFN
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis c focused on measuring hepatitis c, metformin, pegylated interferon
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
Sites / Locations
- Kaohsiung Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
metformin, pegylated-IFN, ribavirin
Pegylated-IFN and ribavirin
Arm Description
metformin,pegylated-IFN and ribavirin
pegylated -IFN and ribavirin
Outcomes
Primary Outcome Measures
sustained virological response
HCV RNA negative 24 weeks after treatment is stopped
Secondary Outcome Measures
change of HOMA-IR
Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
Full Information
NCT ID
NCT01664845
First Posted
August 10, 2012
Last Updated
August 13, 2012
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT01664845
Brief Title
Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Official Title
Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis c, Insulin Resistance
Keywords
hepatitis c, metformin, pegylated interferon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
metformin, pegylated-IFN, ribavirin
Arm Type
Active Comparator
Arm Description
metformin,pegylated-IFN and ribavirin
Arm Title
Pegylated-IFN and ribavirin
Arm Type
Placebo Comparator
Arm Description
pegylated -IFN and ribavirin
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
glucophage
Intervention Description
metformin 500mg tid
Intervention Type
Drug
Intervention Name(s)
pegylated-IFN
Other Intervention Name(s)
pegasys
Intervention Description
pegasys 180 mcg qw
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
ribavirin 800-1200 mg qd according to BW
Primary Outcome Measure Information:
Title
sustained virological response
Description
HCV RNA negative 24 weeks after treatment is stopped
Time Frame
24 weeks after treatment is stopped
Secondary Outcome Measure Information:
Title
change of HOMA-IR
Description
Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
Time Frame
Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment
Other Pre-specified Outcome Measures:
Title
RVR
Description
HCV RNA At 4 weeks
Time Frame
HCV RNA At 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Lun Tsai, MD
Phone
886-7-3422121
Ext
2075
Email
tsaiwl@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Lun Tsai, MD
Organizational Affiliation
Department of Gastroenterology, Kaohsoung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Lun Tsai, MD
Phone
886-7-3422121
Ext
2075
Email
tsaiwl@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Wei-Lun Tsai, MD
12. IPD Sharing Statement
Learn more about this trial
Effects of Metformin, Pegylated Interferon Alpha and Ribavirin for Chronic Hepatitis C With Insulin Resistance
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