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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00456248
Other study ID # VRX-CIFN-402
Secondary ID
Status Terminated
Phase Phase 4
First received April 2, 2007
Last updated October 11, 2012
Start date February 2007
Est. completion date October 2007

Study information

Verified date October 2012
Source Kadmon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Infergen and ribavirin
Infergen 15 ug QD plus RBV for 36 weeks and Infergen 15 ug QD plus RBV for 48 weeks

Locations

Country Name City State
United States Atlantic Gastroenterology Associates Atlanta Georgia
United States Liver Institute at Methodist Dallas Dallas Texas
United States Caroline Digestive Health Associates Harrisburg North Carolina
United States Tulane University School of Medicine New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Kadmon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the proportion of patients with a sustained viral response (SVR) defined as undetectable serum HCV RNA at the end of the 24 week post-treatment follow-up period. 1.5 years No
Secondary Compare proportion of patients with SVR after switching treatment with Infergen/Ribavirin for 48 weeks versus those treated for 36 weeks 1.5 years No
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