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Sponsors and Collaborators: |
Weill Medical College of Cornell University National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00277758 |
This is a treatment study trial, in which we will assess the safety and tolerability of daily dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV for 48 weeks in the treatment of chronic Hepatitis C.
Condition | Intervention | Phase |
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Hepatitis C |
Biological: Interleukin 2 Drug: Ribavirin Biological: Pegylated Interferon Alpha Biological: Inteleukin-2 Drug: Ribavirin + Pegylated interferon-alpha |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Low Dose Interleukin 2 (IL-2)Monotherapy, Followed by IL-2 Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I Infection |
Enrollment: | 18 |
Study Start Date: | March 2004 |
Study Completion Date: | August 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Interventions: 12 weeks of interleukin-2 administration, followed by 48 weeks of interleukin-2 + Ribavirin + interferon-alpha therapy, followed by 24 weeks off therapy
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Biological: Interleukin 2
Interleukin-2 at 1.2 mU/M2 administered subcutaneously daily
Drug: Ribavirin
Ribavirin @ 800 mg daily (< 65 kg body weight), 1000 mg (65-85 kg), and 1200 mg (> 85 kg)
Biological: Pegylated Interferon Alpha
Pegylated-Interferon-alpha 1.5 ug/kg weekly subcutaneously.
Biological: Inteleukin-2
Interleukin-2 administered as a daily subcutaneous injection at 1.2 mU/M2 BSA
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2: Active Comparator
48 weeks of therapy with Ribavirin + interferon-alpha, followed by 24 weeks off therapy
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Drug: Ribavirin
Ribavirin @ 800 mg daily (< 65 kg body weight), 1000 mg (65-85 kg), and 1200 mg (> 85 kg)
Biological: Pegylated Interferon Alpha
Pegylated-Interferon-alpha 1.5 ug/kg weekly subcutaneously.
Drug: Ribavirin + Pegylated interferon-alpha
Pegylated interferon-alpha administered 1.5 ug/kg weekly. Ribivirin 800 mg daily for body weight <65 kg, 1000 mg for body weight 65-85 kg, and 1200 mg for body weight >85 kg.
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This is a single center study of 12 weeks of IL-2 lead in immunotherapy followed by 48 weeks of IL2 immunotherapy in combination with Pegylated Interferon Alpha (PEG-IFN-alpha) /Ribavirin (RBV) antiviral therapy for the treatment of individuals infected with Hepatitis C virus (HCV) genotype I. The study is designed to determine whether immunotherapy immunotherapy with low dose daily IL-2 can be safely added to the standard antiviral therapy of 48 weeks of PEG-IFN and RBV. Because IL-2 targets recently antigen- activated T cells, IL-2 therapy will be initiated 12 weeks before PEG-IFN/RBV therapy, when HCV antigen load is high, to activate and expand HCV antigen-specific T cells prior to the initiation of antiviral therapy.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women of reproductive potential (defined for this study as sexually mature women who have not been post-menopausal for at least 24 consecutive months, or have not undergone hysterectomy or oophorectomy) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 MIU/mL performed within 30 days prior to enrollment and again within 24 hours before initiating study therapy.
All subjects must not participate in a conception process, and if participating in sexual activity that could lead to pregnancy, male subjects must take every precaution to avoid risk of pregnancy for their female partners, women subjects/male partners must use two reliable methods of contraception simultaneously, while receiving study therapy and for 6 months following permanent discontinuation of study therapy.
NOTE A: Reliable forms of contraception are a combination of two of the following methods: 1) condoms (male or female) with or without a spermicidal agent. 2) diaphragm or cervical cap with spermicide, 3) IUD, or 4) hormonal-based contraception.
NOTE B: An IUD is an adequate method of contraception but increases the risk of pelvic inflammatory disease.
Exclusion Criteria:
Therefore, subjects > 40 years of age with ≥ 1 risk factor for ASHD (i.e., hyperlipidemia, hypertension, smoking history, family history) should have an EKG preformed. If the EKG is abnormal and consistent with ischemic heart disease, the subject should have a cardiac stress test to R/O ASHD.
NOTE: If screening TSH is abnormal, obtain free thyroxin index. If the free thyroxine index is normal, the subject may enter the study. If the free thyroxin index is low, the subject may be treated with thyroid hormone replacement medication and enter the study once the free thyroxin index is corrected. If the free thyroxin index is elevated indicating hyperthyroidism, the subject should not enroll in the study.
Patients with preexistent antibodies against thyroid peroxidase or thyroglobulin should not be enrolled.
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10021 |
Principal Investigator: | Kendall A Smith, MD | Weill Medical College of Cornell University |
Responsible Party: | weill Medical College of Cornell University ( Kendall A. Smith, Professor of Medicine ) |
Study ID Numbers: | 00-092, UO1 AI48224 |
Study First Received: | January 12, 2006 |
Last Updated: | March 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00277758 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Interleukin-2 |
Antimetabolites Anti-Infective Agents Liver Diseases Interferon Type I, Recombinant Hepatitis, Chronic Immunologic Factors Ribavirin Hepatitis, Viral, Human Hepatitis C Analgesics Interferon-alpha Interferons Antiviral Agents |
Angiogenesis Inhibitors Virus Diseases Hepatitis Aldesleukin Digestive System Diseases Interleukin-2 Analgesics, Non-Narcotic Peginterferon alfa-2b Peripheral Nervous System Agents Interferon Alfa-2a Interferon Alfa-2b Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Liver Diseases Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Hepatitis, Chronic Immunologic Factors Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Sensory System Agents Therapeutic Uses Analgesics |
Growth Inhibitors Hepatitis C Angiogenesis Modulating Agents Interferon-alpha RNA Virus Infections Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Analgesics, Non-Narcotic Interleukin-2 |