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The Effect of Adding Metformin to the Treatment of Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00560690
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
Shahin Merat, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE November 19, 2007
First Posted Date  ICMJE November 20, 2007
Last Update Posted Date April 6, 2015
Study Start Date  ICMJE December 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2007)
Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment [ Time Frame: 6 months after end of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00560690 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2007)
  • adverse effects leading to discontinuation of treatment [ Time Frame: anytime during the study ]
  • Rapid viral response, defined as undetectable viral RNA one month after start of treatment [ Time Frame: one month after start of treatment ]
  • Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment [ Time Frame: three months after start of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Adding Metformin to the Treatment of Hepatitis C
Official Title  ICMJE Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response
Brief Summary

Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients

We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial

Detailed Description Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Metformin
    500 mg oral three times a day for 6 months
  • Drug: pegylated interferon
    180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype
  • Drug: Ribavirin
    800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    standard treatment with pegylated interferon and ribavirin + placebo
    Interventions:
    • Drug: pegylated interferon
    • Drug: Ribavirin
  • Experimental: Metformin
    standard treatment with pegylated interferon and ribavirin + metformin
    Interventions:
    • Drug: Metformin
    • Drug: pegylated interferon
    • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2015)
140
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2007)
130
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • chronic hepatitis C
  • Iranian nationality
  • Treatment naive

Exclusion Criteria:

  • cirrhosis
  • diabetes mellitus
  • HBV/HIV coinfection
  • contraindications of metformin, interferon, ribavirin
  • severe medical conditions (e.g. CHF, CRF, psychosis, ...)
  • not consenting
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00560690
Other Study ID Numbers  ICMJE 83/53
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shahin Merat, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shahin Merat, MD Digestive Disease Research Center, Medical Sciences / University of Tehran
Study Chair: Reza Malekzadeh, MD Digestive Disease Research Center, Medical Sciences / University of Tehran
PRS Account Tehran University of Medical Sciences
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP