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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239252
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : August 26, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Interferon alfacon-1 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00239252     History of Changes
Other Study ID Numbers: B6431/HCT1
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014

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

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