Observational Prospective Registry of the Efficacy, Safety, and Adherence to Infergen® in Patients Infected With Hep C

• Status: Withdrawn
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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 prescribed therapies in patients chronically infected with HCV. The primary endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kadmon Pharmaceuticals
• Treatments: Interferon alfacon-1; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

1. Willing to consent to data being collected and provided to the Duke Clinical Research Institute (DCRI) and Three Rivers Pharmaceuticals

2. 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

3. Anti-HCV antibody-positive

4. 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

5. Deemed by the investigator to be an appropriate patient for treatment with Infergen and other prescribed medications

6. Baseline CD4 count >200 cells/mm3 (human immunodeficiency virus [HIV]-HCV coinfected patients)

7. 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.

8. Women: must not be lactating and, if of childbearing potential, must have a negative serum pregnancy test result at the baseline visit

9. Age >18 years

Exclusion Criteria:

1. Unable to complete all clinic visits and comply with registry procedures, including self-injection of Infergen

2. Known hypersensitivity to alpha-interferons or any component of the product

3. Decompensated hepatic disease

4. Autoimmune hepatitis

5. Hemoglobinopathies (i.e., thalassemia or sickle cell anemia)

6. 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