NCT00560690

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

November 19, 2007

Last Update Submit

April 2, 2015

Conditions

Hepatitis C

Keywords

Hepatitis CmetforminInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment

    6 months after end of treatment

Secondary Outcomes (3)

  • adverse effects leading to discontinuation of treatment

    anytime during the study

  • Rapid viral response, defined as undetectable viral RNA one month after start of treatment

    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

    three months after start of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

standard treatment with pegylated interferon and ribavirin + placebo

Drug: pegylated interferonDrug: Ribavirin

Metformin

EXPERIMENTAL

standard treatment with pegylated interferon and ribavirin + metformin

Drug: MetforminDrug: pegylated interferonDrug: Ribavirin

Interventions

MetforminDRUG

500 mg oral three times a day for 6 months

Metformin
pegylated interferonDRUG

180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype

MetforminPlacebo
RibavirinDRUG

800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype

MetforminPlacebo

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • chronic hepatitis C
  • Iranian nationality
  • Treatment naive

You may not qualify if:

  • cirrhosis
  • diabetes mellitus
  • HBV/HIV coinfection
  • contraindications of metformin, interferon, ribavirin
  • severe medical conditions (e.g. CHF, CRF, psychosis, ...)
  • not consenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shariati Hospital

Tehran, Tehran Province, 14114, Iran

Location

MeSH Terms

Conditions

Hepatitis CInsulin Resistance

Interventions

MetforminRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsRibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Shahin Merat, MD

    Digestive Disease Research Center, Medical Sciences / University of Tehran

    PRINCIPAL INVESTIGATOR

  • Reza Malekzadeh, MD

    Digestive Disease Research Center, Medical Sciences / University of Tehran

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

IR(1)