ClinicalTrials.gg
Sign In
Status unknownNCT01664845Updated Aug 14, 2012

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

A Phase 2/3 interventional study of metformin and pegylated-IFN in Chronic Hepatitis c and Insulin Resistance, sponsored by Kaohsiung Veterans General Hospital.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-08-14.

Sponsored by Kaohsiung Veterans General Hospital. · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Chronic Hepatitis c
  • Insulin Resistance

Keywords

  • hepatitis c
  • metformin
  • pegylated interferon
03

In context

Hepatitis C, Chronic

1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's planned enrollment of 120 is above the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.

Browse Hepatitis C, Chronic studies →

Lead sponsor

Kaohsiung Veterans General Hospital. is the lead sponsor of 106 studies on the registry; 12 are open to participants now.

Browse Kaohsiung Veterans General Hospital. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • HCV RNA (+) and ALT > 40 U/L
  • Compensated liver
  • HOMA-IR > 2

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    metformin, pegylated-IFN, ribavirin

    metformin,pegylated-IFN and ribavirin

    Drug: metformin · Drug: pegylated-IFN · Drug: ribavirin

  • Placebo comparator
    Pegylated-IFN and ribavirin

    pegylated -IFN and ribavirin

    Drug: pegylated-IFN · Drug: ribavirin

Interventions

  • Drugmetformin

    metformin 500mg tid

    Also known as: glucophage

  • Drugpegylated-IFN

    pegasys 180 mcg qw

    Also known as: pegasys

  • Drugribavirin

    ribavirin 800-1200 mg qd according to BW

06

What researchers measure

Primary outcomes

  1. sustained virological response

    HCV RNA negative 24 weeks after treatment is stopped

    Time frame: 24 weeks after treatment is stopped

Secondary outcomes

  1. change of HOMA-IR

    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 outcomes

  1. RVR

    HCV RNA At 4 weeks

    Time frame: HCV RNA At 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Veterans General Hospital
    Kaohsiung, Taiwan 813, Taiwan
    • Wei-Lun Tsai, MD · Contact · tsaiwl@yahoo.com.tw · 886-7-3422121
    • Wei-Lun Tsai, MD · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2012
First posted
Aug 14, 2012
Start
Aug 2012
Primary completionEst.
Aug 2014
CompletionEst.
Aug 2014
Last update
Aug 14, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01664845
Lead sponsor
Kaohsiung Veterans General Hospital.
Responsible party
Wei-Lun Tsai (Attending physician, Kaohsiung Veterans General Hospital.) — Principal investigator
First posted
Aug 14, 2012
Start date
Aug 2012
Primary completion
Aug 2014 (estimated)
Completion
Aug 2014 (estimated)
Last update
Aug 14, 2012

Study contacts

Wei-Lun Tsai, MD
Contact
tsaiwl@yahoo.com.tw
886-7-3422121 ext. 2075
Wei-Lun Tsai, MD
principal investigator · Department of Gastroenterology, Kaohsoung Veterans General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Metformin

Other studies in this condition

Hepatitis C, Chronic →

Other studies from this sponsor

Kaohsiung Veterans General Hospital. →

Start the discussion