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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

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00239252
First received: September 13, 2005
Last updated: August 25, 2008
Last verified: August 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239252

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

No publications provided

ClinicalTrials.gov Identifier: NCT00239252     History of Changes
Other Study ID Numbers: B6431/HCT1
Study First Received: September 13, 2005
Last Updated: August 25, 2008
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
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Interferons
Interferon alfacon-1
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013