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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: September 13, 2005
Last updated: August 25, 2014
Last verified: August 2014
Efficacy and safety is compared between interferon alfacon-1 alone and concomitant dosing of interferon alfacon-1 and ribavirin in hepatitis C patients.

Condition Intervention Phase
Hepatitis C
Drug: Interferon alfacon-1
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00239252

Chubu region, Japan
Chugoku region, Japan
Kinki region, Japan
Kyushu region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Clinical Development III Astellas Pharm. Inc.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00239252     History of Changes
Other Study ID Numbers: B6431/HCT1 
Study First Received: September 13, 2005
Last Updated: August 25, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Interferon alfacon-1
Virus disease
Hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon alfacon-1
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 26, 2016