Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
Information source: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C
Intervention: 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 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Valeant Pharmaceuticals International, Inc. Official(s) and/or principal investigator(s): Ralph T. Doyle, Study Director, Affiliation: Valeant Pharmaceuticals International, Inc.
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.
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
(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
Locations and Contacts
Additional Information
Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy
Starting date: February 2005
Last updated: June 21, 2012
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