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

NCT00951223 | Withdrawn DMC

• 1 other identifier: CIFN 003
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Determine the incidence of SVR, defined as undetectable HCV RNA measured 24 weeks after therapy ends, associated with prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) in patients chronically infected with HCV.

  24 weeks post end of therapy

Secondary Outcomes (1)

• Capture of defined adverse events (AEs),dose changes or cessation, and adherence to the prescribed dose of Infergen and other prescribed therapies over the course of treatment

  Treatment weeks 4, 12, 24, 48, and Follow-Up weeks 4 and 24

Study Arms (1)

Patients with Chronic Hepatitis C

HCV positive patients who have failed previous HCV therapy This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patientadministered 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. Safety will be assessed by monitoring AEs, reduction/discontinuation of therapy because of AEs, routine laboratory results and by other means determined by the Investigator

Drug: Infergen® (Interferon alfacon-1)

Interventions

Infergen® (Interferon alfacon-1) DRUG

Infergen at either the 15 mcg or 9 mcg dose given per Providers instructions, with or without weight based ribavirin

Also known as: INF

Patients with Chronic Hepatitis C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Community Gastrointestinal Practices as well as Academic Centers will be asked to participate

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kadmon Corporation, LLC: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

interferon alfacon-1

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Andrew Muir, MD

  DCRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 4, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: April 1, 2011
• Last Updated: September 3, 2015

Record last verified: 2015-09