NCT01664845

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

August 10, 2012

Last Update Submit

August 13, 2012

Conditions

Chronic Hepatitis cInsulin Resistance

Keywords

hepatitis cmetforminpegylated interferon

Outcome Measures

Primary Outcomes (1)

  • sustained virological response

    HCV RNA negative 24 weeks after treatment is stopped

    24 weeks after treatment is stopped

Secondary Outcomes (1)

  • change of HOMA-IR

    Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment

Other Outcomes (1)

  • RVR

    HCV RNA At 4 weeks

Study Arms (2)

metformin, pegylated-IFN, ribavirin

ACTIVE COMPARATOR

metformin,pegylated-IFN and ribavirin

Drug: metforminDrug: pegylated-IFNDrug: ribavirin

Pegylated-IFN and ribavirin

PLACEBO COMPARATOR

pegylated -IFN and ribavirin

Drug: pegylated-IFNDrug: ribavirin

Interventions

metforminDRUG

metformin 500mg tid

Also known as: glucophage
metformin, pegylated-IFN, ribavirin
pegylated-IFNDRUG

pegasys 180 mcg qw

Also known as: pegasys
Pegylated-IFN and ribavirinmetformin, pegylated-IFN, ribavirin
ribavirinDRUG

ribavirin 800-1200 mg qd according to BW

Pegylated-IFN and ribavirinmetformin, pegylated-IFN, ribavirin

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 813, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis C, ChronicInsulin ResistanceHepatitis C

Interventions

Metforminpeginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsRibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Wei-Lun Tsai, MD

    Department of Gastroenterology, Kaohsoung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Lun Tsai, MD

CONTACT

886-7-3422121tsaiwl@yahoo.com.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

TW(1)