PEG-IFN Plus Ribavirin Combination Therapy for Older Pati... | NCT00956982

Studies
PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

NCT00956982

Sponsor

Kyushu University

Status

Unknown status

Last Update Posted

Aug 11, 2009Estimated

Enrollment

1,251Estimated

Phase

Not Applicable

Conditions

Hepatitis C Virus

Interventions

Pegylated interferon alpha-2b plus ribavirin

Countries

Japan

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 2009

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

Dec 2004

Primary Completion Date

Jul 2008Actual

Completion Date

Dec 2012Estimated

First Submitted Date

Aug 6, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 11, 2009Estimated

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 10, 2009

Last Update Posted Date

Aug 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,251Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pegylated interferon alpha-2b plus ribavirin	Drug	All patients were treated with a weight-based, 1.5 μg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
antiviral effect by PEG-IFN alpha-2b plus RBV treatment		24-weeks follow-up after the end of treatment

Secondary Outcomes

Measure	Description	Time Frame
the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment		during PEG-IFN alpha-2b plus RBV treatment (48 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.
All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.

Exclusion Criteria:

Clinical or biochemical evidence of hepatic decompensation.
Advanced cirrhosis identified by large esophageal varices (F2 or F3).
History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ.
Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
Excessive active alcohol consumption > 60 g/day or drug abuse.
Severe psychiatric disease.
Antiviral or corticosteroid therapy within 12 months prior to the enrollment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Hayashi	Contact	+81-92-642-5909		hayashij@genmedpr.med.kyushu-u.ac.jp

Overall Officials

Name	Affiliation	Role
Jun Hayashi	Department of General Medicine, Kyushu University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of General Medicine, Kyushu University Hospital	Recruiting	Fukuoka		812-8582	Japan

Condition Browse Module

MeSH Terms

ID	Term
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
C417083	peginterferon alfa-2b
D012254	Ribavirin

Ancestor Terms

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided