Effects of Metformin, Pegylated Interferon Alpha and Riba... | NCT01664845

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

NCT01664845

Sponsor

Kaohsiung Veterans General Hospital.

Status

Unknown status

Last Update Posted

Aug 14, 2012Estimated

Enrollment

120Estimated

Phase

Phase 2Phase 3

Conditions

Chronic Hepatitis c
Insulin Resistance

Interventions

metformin
pegylated-IFN
ribavirin

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Aug 2014Estimated

Completion Date

Aug 2014Estimated

First Submitted Date

Aug 10, 2012

First Submission Date that Met QC Criteria

Aug 13, 2012

First Posted Date

Aug 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2012

Last Update Posted Date

Aug 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei-Lun Tsai, Attending physician, Kaohsiung Veterans General Hospital.Principal Investigator

Lead Sponsor

Kaohsiung Veterans General Hospital.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metformin, pegylated-IFN, ribavirin	Active Comparator	metformin,pegylated-IFN and ribavirin	Drug: metformin Drug: pegylated-IFN Drug: ribavirin
Pegylated-IFN and ribavirin	Placebo Comparator	pegylated -IFN and ribavirin	Drug: pegylated-IFN Drug: ribavirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
metformin	Drug	metformin 500mg tid	metformin, pegylated-IFN, ribavirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sustained virological response	HCV RNA negative 24 weeks after treatment is stopped	24 weeks after treatment is stopped

Secondary Outcomes

Measure	Description	Time Frame
change of HOMA-IR	Check Serial change HOMA-IR at baseline, 4 weeks and 12 weeks after treatment	Serial change of HOMA-IR at baseline, 4 weeks and 12 weeks after treatment

Other Outcomes

Measure	Description	Time Frame
RVR	HCV RNA At 4 weeks	HCV RNA At 4 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei-Lun Tsai, MD	Contact	886-7-3422121	2075	tsaiwl@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Wei-Lun Tsai, MD	Department of Gastroenterology, Kaohsoung Veterans General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Veterans General Hospital	Recruiting	Kaohsiung	Taiwan	813	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic
D007333	Insulin Resistance
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin
C100416	peginterferon alfa-2a
D012254	Ribavirin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D012263

Browse Leaves

Not provided

Browse Branches

Not provided