Observational Prospective Registry of the Efficacy, Safety, and Adherence to Therapy of Infergen® (Interferon Alfacon 1) in Patients Chronically Infected With Hepatitis C Virus (REACH SVR)

This study has been terminated.
Sponsor:
Information provided by:
Kadmon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00951223
First received: August 3, 2009
Last updated: May 23, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Hepatitis C
Drug: Infergen with or without ribavirin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Prospective Registry of the Efficacy, Safety, and Adherence to Therapy of Infergen® (Interferon Alfacon 1) in Patients Chronically Infected With Hepatitis C Virus

Resource links provided by NLM:


Further study details as provided by Kadmon Pharmaceuticals:

Primary Outcome Measures:
  • 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. [ Time Frame: 24 weeks post end of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Treatment weeks 4, 12, 24, 48, and Follow-Up weeks 4 and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: August 2009
Estimated Study Completion Date: April 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Chronic Hepatitis C Drug: Infergen with or without ribavirin
Infergen at either the 15 mcg or 9 mcg dose given per Providers instructions, with or without weight based ribavirin

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. Patients can have any HCV genotype; they also can be antiviral treatment-naïve or have a history of either nonresponse or relapse to previous antiviral therapy. Patients can roll over directly from current interferon (IFN) therapy into registry Infergen therapy, but the average washout period will be <1 month. Rollovers will occur after 4, 12, or 24 weeks of IFN therapy. Patients coinfected with HBV or HIV can be included in the registry.

Each investigator participating in this registry will employ his or her discretion and standard clinical practice to determine when to see the patient in the clinic, how to manage the patient's drug regimen, and how best to monitor the patient's response and tolerance to therapy.The decision to enroll a patient and start therapy with Infergen and other prescribed therapies may be guided by historic biopsy results, or the patient can undergo liver biopsy at the investigator's discretion. Biopsy is not a prerequisite, however, if the investigator believes it to be unnecessary. When a patient's treatment is expected to require significant dose modification and/or more intensive monitoring because of comorbid conditions, enrolling the patient in the registry is at the investigator's discretion. For purposes of the registry, data will be collected at baseline; at Weeks 4, 12, 24, and 48 from the start of therapy; and at follow-up visits 4 and 24 weeks after treatment 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. Adherence over the course of therapy will also be evaluated, taking into account physician-directed dose reduction or cessation, patients' self-reports of compliance, and the return of used and unused medication to each scheduled visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951223

  Show 58 Study Locations
Sponsors and Collaborators
Kadmon Pharmaceuticals
Investigators
Principal Investigator: Andrew Muir, MD DCRI
  More Information

No publications provided

Responsible Party: John McHutchison, MD, Duke Clinical Research
ClinicalTrials.gov Identifier: NCT00951223     History of Changes
Other Study ID Numbers: CIFN 003
Study First Received: August 3, 2009
Last Updated: May 23, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon alfacon-1
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014