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Infergen and Ribavirin Treatment of Patients With HCV Who Achieved Partial Response to Peginterferon-alfa and Ribavirin

NCT ID: NCT00456248

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-10-31

Brief Summary

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This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States.

Detailed Description

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Conditions

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Hepatitis C

Keywords

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Chronic Hepatitis C Liver Pegylated Interferon Ribavirin Combination Nonresponder Relapser HCV Infergen SVR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Infergen 15 ug QD plus RBV for 36 weeks

Group Type EXPERIMENTAL

Infergen and ribavirin

Intervention Type DRUG

Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

2

Infergen 15 ug QD plus RBV for 48 weeks

Group Type EXPERIMENTAL

Infergen and ribavirin

Intervention Type DRUG

Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

3

Group Type ACTIVE_COMPARATOR

Infergen and ribavirin

Intervention Type DRUG

Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

Interventions

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Infergen and ribavirin

Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, at least 18 years of age and no older than 65 years with compensated chronic HCV infection based on a history of positive serum anti-HCV antibody and/or HCV RNA
* Diagnosed with HCV Genotype 1, 4, 5 or 6 as determined during the screening visit
* The starting doses in the initial treatment must have been 1.5 μg/kg/week PEG-Intron or 180 μg/week Pegasys, and 1000/1200 mg/day ribavirin based on body weight. Patients must have been at least 80% compliant during the initial peginterferon/ribavirin therapy, per patient account.
* Liver biopsy indicating F0-F4 must be performed within 3 years prior to screening. Documentation of the results of the biopsy must be available. If documentation is not available, a liver biopsy must be performed during the screening period. (A maximum of 10 patients in each of the three treatment groups will be patients with a fibrosis score of F4)
* Documented partial response after 12 weeks of treatment as a therapy-naive patient with one course of peginterferon alfa-2a (PEGASYS) and Ribavirin or peginterferon alfa-2b (Peg-INTRON) and Ribavirin

Exclusion Criteria

* Detectable HCV RNA after 12 weeks if initial peginterferon alfa/ribavirin therapy and \<2 log decrease in HCV RNA at Week 12 from baseline.
* HCV Genotype 2 or 3
* Severe neuropsychiatric disorder.
* History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease.
* Known HIV infection or positive HIV at screening.
* Pregnant or breast-feeding patients.
* Underlying autoimmune disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kadmon Corporation, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell L Schiffman, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Atlantic Gastroenterology Associates

Atlanta, Georgia, United States

Site Status

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status

Caroline Digestive Health Associates

Harrisburg, North Carolina, United States

Site Status

Liver Institute at Methodist Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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VRX-CIFN-402

Identifier Type: -

Identifier Source: org_study_id