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
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Interferon alfacon-1, Virus disease, Hepatitis C
Eligibility Criteria
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
No
Eligibility Criteria
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
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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