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NCT00239252 Clinical Trial

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

Hepatitis C Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00239252
Other study ID # B6431/HCT1
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated August 25, 2014

Study information
Verified date August 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Interferon alfacon-1

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Schering-Plough

Country where clinical trial is conducted

Japan, 

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