Status:
WITHDRAWN
Observational Prospective Registry of the Efficacy, Safety, and Adherence to Infergen® in Patients Infected With Hep C
Lead Sponsor:
Kadmon Corporation, LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) and other prescrib...
Detailed Description
This registry plans to enroll 1000 patients at 75 clinical sites across the United States. Potentially eligible patients will be anti-HCV antibody-positive and have detectable serum or plasma HCV RNA...
Eligibility Criteria
Inclusion
- Willing to consent to data being collected and provided to the Duke Clinical Research Institute (DCRI) and Three Rivers Pharmaceuticals
- Able and willing to give written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, and to comply with the requirements of the registry protocol
- Anti-HCV antibody-positive
- HCV RNA concentration \>100,000 IU/mL on reverse transcriptase-polymerase chain reaction (RT-PCR) assay at baseline or \>90 days before the baseline visit
- Deemed by the investigator to be an appropriate patient for treatment with Infergen and other prescribed medications
- Baseline CD4 count \>200 cells/mm3 (human immunodeficiency virus \[HIV\]-HCV coinfected patients)
- Women: must be documented to be surgically sterile, be postmenopausal (defined as \>2 years without menses), or agree to use 2 forms of effective contraception during the registry and for 6 months after receiving the final dose of study drug. Men: must agree to use 2 forms of effective contraception during the registry and for 6 months after receiving the final dose of study drug, and their partners of childbearing potential must not be pregnant at screening.
- Women: must not be lactating and, if of childbearing potential, must have a negative serum pregnancy test result at the baseline visit
- Age \>18 years
Exclusion
- Unable to complete all clinic visits and comply with registry procedures, including self-injection of Infergen
- Known hypersensitivity to alpha-interferons or any component of the product
- Decompensated hepatic disease
- Autoimmune hepatitis
- Hemoglobinopathies (i.e., thalassemia or sickle cell anemia)
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in and completing the registry
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00951223
Start Date
August 1 2009
End Date
April 1 2011
Last Update
September 3 2015
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