Comparative Trial of Standard Versus Low-dose Peg-Interfe... | NCT00216775

Studies
Comparative Trial of Standard Versus Low-dose Peg-Interferon Plus Ribavirin in the Treatment of Chronic Hepatitis C

NCT00216775

Sponsor

Kyoto University

Status

Completed

Last Update Posted

Sep 2, 2015Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Hepatitis C, Chronic

Interventions

interferon-alfa-2b and 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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Sep 10, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

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

Sep 1, 2015

Last Update Posted Date

Sep 2, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
interferon-alfa-2b and ribavirin	Drug

Measure	Description	Time Frame
rate of sustained viral response		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses

Exclusion Criteria:

Hemoglobin levels<8.5g/dL,
Platelet counts<50,000/mm3,
Total polymorphonuclear counts<1000/mm3
Pregnancy,
Renal dysfunction,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients with chronic hepatitis C

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tsutomu Chiba, M.D., Ph.D	Kyoto University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology and Hepatology, Kyoto University Hospital		Kyoto		606-8507	Japan

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007438	Introns
D012254	Ribavirin

Ancestor Terms

ID	Term
D021901	DNA, Intergenic
D040481	Genome Components
D016678	Genome
D040342	Genetic Structures

Browse Leaves

Not provided

Browse Branches

Not provided