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

Condition(s) targeted: Hepatitis C

Intervention: Infergen with or without ribavirin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Three Rivers Pharmaceuticals

Official(s) and/or principal investigator(s):
Andrew Muir, MD, Principal Investigator, Affiliation: Duke University

Overall contact:
Amanda Beard, Phone: 919-668-7812, Email: amanda.beard@duke.edu

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.

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: 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.

Secondary outcome: 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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Amanda Beard, Phone: 919-668-7812, Email: amanda.beard@duke.edu

Dr. Maribel Rodriguez-Torres, MD, San Juan, Puerto Rico; Recruiting

Dr. Donald Marks, Birmingham, Alabama 35233, United States; Recruiting

Dr. Gary Abrams, MD, Montgomery, Alabama 36116, United States; Recruiting

Dr. Anayochukwu Uche, MD, Bullhead City, Arizona 86442, United States; Recruiting

Dr. Murray Cohen, DO, Phoenix, Arizona 85015, United States; Recruiting

Vicki McIntyre, FNP, Tucson, Arizona 85712, United States; Recruiting

Dr. Scott Wilson, MD, Tucson, Arizona 85745, United States; Recruiting

Dr. Ashesh Sanghvi, MD, Yuma, Arizona 85364, United States; Recruiting

Dr. James Rose, MD, Little Rock, Arkansas 72205, United States; Recruiting

Dr. Franco Felizarta, MD, Bakersfield, California 93301, United States; Recruiting

Dr. Mohamed Elkabany, MD, Loma Linda, California 92354, United States; Recruiting

Dr. Naeem Akhtar, MD, Madera, California 93637, United States; Recruiting

Dr. Tarek Hassanein, San Clemente, California 92673, United States; Recruiting

Dr. Tuan Nguyen, MD, San Diego, California 92105, United States; Recruiting

Dr. Alexander Kuo, MD, San Diego, California 92103, United States; Recruiting

Dr. Bahri Bilir, MD, Littleton, Colorado 80120, United States; Recruiting

Dr. Steven Gorelick, MD, Danbury, Connecticut 06810, United States; Recruiting

Dr. Martin Hoffman, MD, Hartford, Connecticut 06105, United States; Recruiting

Kathryn Jack, NP, Meriden, Connecticut 06451, United States; Recruiting

Dr. Joseph Lim, MD, New Haven, Connecticut 06520, United States; Recruiting

Dr. Maria Sjogren, MD, Washington, District of Columbia 20307, United States; Recruiting

Dr. Edwin DeJesus, MD, Orlando, Florida 32803, United States; Recruiting

Dr. Ronald Barbour, MD, Tampa, Florida 33613, United States; Recruiting

Dr. Alfredo Mendoza, MD, Tampa, Florida 33606, United States; Recruiting

Dr. Brian Pearlman, MD, Atlanta, Georgia 30309, United States; Recruiting

Dr. Richard Prokesh, MD, Riverdale, Georgia 30274, United States; Recruiting

Dr. Naoky Tsai, MD, Honolulu, Hawaii 96817, United States; Recruiting

Dr. Anjana Pillai, MD, Maywood, Illinois 60153, United States; Recruiting

Dr. Shoba Joshi, MD, New Orleans, Louisiana 70121, United States; Recruiting

Dr. Dasarathy Srinivas, Slidell, Louisiana 70458, United States; Recruiting

Dr. Lawton Shick, Boston, Massachusetts 02111, United States; Recruiting

Dr. Fred Gordon, MD, Burlington, Massachusetts 01805, United States; Recruiting

Dr. Claudia Martorell, MD, Springfield, Massachusetts 01107, United States; Recruiting

Dr. George Abraham, MD, Worcester, Massachusetts 01608, United States; Recruiting

Dr. Bradley Freilich, MD, Kansas City, Missouri 64131, United States; Recruiting

Dr. Bruce Bacon, MD, St. Louis, Missouri 63110, United States; Recruiting

Dr. Jihad Slim, MD, Newark, New Jersey 07102, United States; Recruiting

Dr. David Stein, MD, Bronx, New York 10463, United States; Recruiting

Dr. Kadirawel Iswara, MD, Brooklyn, New York 11229, United States; Recruiting

Dr. Melissa Palmer, MD, New York, New York 11803, United States; Recruiting

Dr. Hillel Tobias, New York, New York 10016, United States; Recruiting

Tiffany Kaiser, PharmD, BCPS, Cincinnati, Ohio 45267, United States; Recruiting

Dr. Paul Schleinitz, MD, Medford, Oregon 97504, United States; Recruiting

Kenneth Ingram, PA-C, Portland, Oregon 97239, United States; Recruiting

Dr. William Wu, MD, Springfield, Oregon 97477, United States; Recruiting

Dr. Tuesdae Stainbrook, MD, DuBois, Pennsylvania 15801, United States; Recruiting

Dr. Kenneth Rothstein, Philadelphia, Pennsylvania 19107, United States; Recruiting

Dr. Geoffrey Block, MD, Pittsburgh, Pennsylvania 15238, United States; Recruiting

Dr. Mordechai Rabinovitz, MD, Pittsburgh, Pennsylvania 15231, United States; Recruiting

Bruce Askey, PA-C, Sayre, Pennsylvania 18840, United States; Recruiting

Dr. Hesham Elgouhari, MD, Sioux Falls, South Dakota 57105, United States; Recruiting

Dr. Parvez Mantry, MD, Dallas, Texas 75203, United States; Recruiting

Dr. Victor Ankoma-Sey, MD, Houston, Texas 77030, United States; Recruiting

Dr. Michael Fallon, MD, Houston, Texas 77030, United States; Recruiting

Dr. Jonathan McCone, MD, Alexandria, Virginia 22036, United States; Recruiting

Dr. Michael Ryan, MD, Norfolk, Virginia 23502, United States; Recruiting

Bobbie Aflatooni, NP, Bellevue, Washington 98004, United States; Recruiting

Dr. Moises Garcia, MD, Milwaukee, Wisconsin 53215, United States; Recruiting

Starting date: August 2009
Last updated: August 2, 2010