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Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy

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: NCT00162734
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : June 22, 2012
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:

This Phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of Infergen (interferon alfacon-1, CIFN) plus Ribavirin administered daily for 48 weeks and no treatment in patients chronically infected with hepatitis C who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy and participated during at least 24 weeks of no treatment in IRHC-001.

At the time of randomization into IRHC-001, the no treatment arm patients will be concurrently randomized in a 1:1 ration to receive Interferon Alfacon-1 (9 or 15 µg) + Ribavirin (both administered daily) or no treatment for up to 48 weeks. Patients will not be eligible for consideration to receive treatment in IRHC-002 until they have completed a minimum of 24 weeks of participation in IRHC-001.

The protocol and informed consent form that will be used must be approved by the Investigator's Institutional Review Board (IRB)/Independent Ethics Committee (IEC) before the study is initiated.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Daily Infergen (Interferon Alfacon-1, CIFN) (9 or 15 µg) + Ribavirin (1000-1200 mg, based on body weight) PO Daily for up to 48 wks Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Study of the Safety and Efficacy of Two Dose Levels of Interferon Alfacon-1 (Infergen, CIFN) Plus Ribavirin Administered Daily for 48 Weeks Versus No Treatment in Hepatitis C Infected Patients Who Are Nonresponders to Previous Pegylated Interferon Alfa Plus Ribavirin Therapy and During at Least 24 Weeks of No Treatment in IRHC-001
Study Start Date : February 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Evaluate sustained virologic response (SVR) rate of daily Infergen at two dose levels plus ribavirin and no treatment in chronically HCV-infected patients who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy. [ Time Frame: 72 weeks ]

Secondary Outcome Measures :
  1. Evaluate safety & tolerability of therapy detailed in primary objective, and proportion of patients with (a) undetectable plasma HCV RNA levels at weeks 24 & 48 (b) abnormal baseline serum ALT levels that are normal at week 24, week 48 and weeks 48 & 72. [ Time Frame: 72 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

(Abbreviated due to space constraints.)

Inclusion Criteria:

  1. Signed informed consent form
  2. Previously randomized to the No-Treatment Arm in IRHC-001 protocol
  3. IRHC-001 no-treatment patients ho have either < 2 log10 reduction in plasma HCV RNA level by bDNA assay at Week 24 compared to baseline or detectable plasma HCV RNA by bDNA or TMA assays at Week 48
  4. All patients and all potentially fertile sexual partners of patients must use 2 reliable forms of effective contraception during the study & for 6 months after cessation of the study drugs

Exclusion Criteria:

  1. Patients who experienced hepatic decompensation during IRHC-001 or show laboratory, clinical, or physiologic evidence of hepatic decompensation at screening for IRHC-002
  2. Patients who, in the opinion of the Investigator or the Sponsor, are not suitable candidates for enrollment or who would not comply w/the requirements of the study
  3. Pregnant or lactating women
  4. Male partners of women who are pregnant
  5. Patients who were on any experimental protocols or therapy while participating in IRHC-001

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): NCT00162734

Sponsors and Collaborators
Bausch Health Americas, Inc.
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Study Director: Ralph T. Doyle Bausch Health Americas, Inc.
Additional Information:
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Responsible Party: Bausch Health Americas, Inc. Identifier: NCT00162734    
Other Study ID Numbers: IRHC-002
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Keywords provided by Bausch Health Americas, Inc.:
Chronic Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
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
Molecular Mechanisms of Pharmacological Action