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Comparison in Efficacy and Safety Between Interferon Alfacon-1 Alone and Concomitant Dosing With Ribavirin for the Treatment of Hepatitis C

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Interferon alfacon-1

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Interferon alfacon-1, Virus disease, Hepatitis C

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hepatitis C patients (high titer, genotype1) Exclusion Criteria: Patients with autoimmune disorder Patients with negative HBs antigen Patients with hepatic cirrhosis, hepatic failure and hepatic cancer Patients with depression or psychoneurotic disorder

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00239252

First Posted

September 13, 2005

Last Updated

August 25, 2014

Sponsor

Astellas Pharma Inc

Collaborators

Schering-Plough

1. Study Identification

Unique Protocol Identification Number

NCT00239252

Brief Title

Comparison in Efficacy and Safety Between Interferon Alfacon-1 Alone and Concomitant Dosing With Ribavirin for the Treatment of Hepatitis C

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

Collaborators

Schering-Plough

4. Oversight

5. Study Description

Brief Summary

Efficacy and safety is compared between interferon alfacon-1 alone and concomitant dosing of interferon alfacon-1 and ribavirin in hepatitis C patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Interferon alfacon-1, Virus disease, Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Interferon alfacon-1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Development III

Organizational Affiliation

Astellas Pharm. Inc.

Official's Role

Study Chair

Facility Information:

City

Chubu region

Country

Japan

City

Chugoku region

Country

Japan

City

Kinki region

Country

Japan

City

Kyushu region

Country

Japan

City

Tohoku region

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrials.jp/user/ctrSearch_e.jsp

Description

Link to Results on JAPIC - enter 140548 in the JapicCTI-RNo. field

Learn more about this trial

Comparison in Efficacy and Safety Between Interferon Alfacon-1 Alone and Concomitant Dosing With Ribavirin for the Treatment of Hepatitis C

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