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Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

Information source: Cangene Corporation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia B

Intervention: IB1001 (On-Demand) (Biological); IB1001 (Prophylaxis) (Biological)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Cangene Corporation

Summary

To evaluate the safety (acute effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of IB1001 in subjects with hemophilia B.

Clinical Details

Official title: Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

Study design: Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: degree of hemorrhage control by treatment regimen

Eligibility

Minimum age: 5 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria: 1. Patient must be willing to give written Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent, make the required study visits, and follow instructions while enrolled in the study 2. Severe (factor IX activity ≤2 U/dL) hemophilia B subjects on demand therapy with a minimum of 3 bleeding episodes over the preceding 6 months or 6 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern as above demonstrated prior to starting prophylaxis 3. Immunocompetent (CD4 count >400/mm3) and not receiving immune modulating or chemotherapeutic agents 4. Previously treated patients with a minimum of 150 exposure days to a factor IX preparation 5. Platelet count at least 150,000/mm3 6. Liver function: alanine transaminase [ALT] and aspartate transaminase [AST] ≤2 times the upper limit of the normal range 7. Total bilirubin ≤1. 5 times the upper limit of the normal range 8. Renal function: serum creatinine ≤1. 25 times the upper limit of the normal range 9. Willingness to participate in the trial for up to 12-15 months 10. European Union (EU), Israel, and Canada: Age of at least 12 years and body weight of ≥40 kilograms to participate in any PK Study or the Surgical Sub-study [the Surgical Sub-study does not apply to the UK]; age of at least 12 years for the prophylaxis and on demand components of the Treatment Phase and Continuation Study United States (US): Age of at least 12 years and body weight of ≥40 kilograms to participate in any PK Study or the Surgical Sub-study; age of at least 5 years for the prophylaxis and on demand components of the Treatment Phase and Continuation Study 11. Hemoglobin ≥7 g/dL at the time of the blood draw Exclusion Criteria: 1. History of factor IX inhibitor ≥0. 6 Bethesda units (BU) 2. Existence of another coagulation disorder 3. Evidence of thrombotic disease, fibrinolysis, or disseminated intravascular coagulation (DIC) 4. Use of an investigational drug within 30 days prior to study entry 5. On medications that could impact hemostasis, such as aspirin 6. History of poor compliance, a serious medical or social condition, or any other circumstance that, in the opinion of the investigator, would interfere with participation or compliance with the study protocol 7. History of adverse reaction to either plasma-derived factor IX or recombinant factor IX that interfered with the subject's ability to treat bleeding episodes with a factor IX product

Locations and Contacts

Hopital Edouard Herriot, Lyon 69437, France

Ospedale di Careggi, Florence I-50134, Italy

University of Milan, Milano I-20122, Italy

MTZ Clinical Research, Warsaw 02-106, Poland

City of Hope, Duarte, California 91010, United States

The Hemophilia Treatment Center of Orthopaedic Hospital, Los Angeles, California 90007, United States

Royal Free Hospital, London, England NW3 2QG, United Kingdom

Manchester Haemophilia Comprehensive Care Manchester Royal Infirmary, Manchester, England M13 9WL, United Kingdom

Royal Hallamshire Hospital, Sheffield, England S102JF, United Kingdom

Emory University School of Medicine Pediatric Hematology, Atlanta, Georgia 30322, United States

Centre for Haemostasis and Thrombosis, Basingstoke and North Hampshire Foundation Trust, Basingstoke, Hampshire RG24 9NA, United Kingdom

Rush University Medical Center-Pediatric Hematology Oncology, Chicago, Illinois 60612, United States

Indiana Hemophilia & Thrombosis Center, Indianapolis, Indiana 46260, United States

Centre Regional de Traitement de l 'Hemophilie, Nantes, Loire-Atlantique 44093, France

Jehangir Clinical Development Centre, Pune, Maharashtra 411 011, India

Sahyadri Specialty Hospital, Deccan Gymkhana, Pune, Maharashtra 411 004, India

University of Minnesota Center for Bleeding and Clotting Disorder, Minneapolis, Minnesota 55455, United States

Hemophilia Treatment Center of Las Vegas, Las Vegas, Nevada 89109, United States

Hemophilia and Thrombosis Center, Cincinnati, Ohio 45229, United States

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

The National Hemophilia Center-Sheba MC, Tel Hashomer, Ramat Gan 52621, Israel

University of Texas Health Science Center-Houston, Gulf States Hemophilia & Thrombophilia Center, Houston, Texas 77030, United States

University Hospital of Wales Health Park, Cardiff, Wales CF4 4XN, United Kingdom

Additional Information

Starting date: January 2009
Last updated: January 29, 2014

Page last updated: August 20, 2015

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