Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B
NCT ID: NCT00768287
Last Updated: 2021-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
77 participants
INTERVENTIONAL
2009-01-31
2016-12-31
Brief Summary
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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.
Key Secondary Objectives:
To evaluate the ability of IB1001 to provide coverage against bleeding under surgical circumstances; To evaluate the long-term safety and efficacy of IB1001
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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IB1001
IB1001
Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa; Study Part 2: Non-randomized, open-label evaluation of prophylaxis and on demand IB1001; Surgical Sub-study: Open-label evaluation of IB1001 during major surgery
nonacog alfa
nonacog alfa
Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa
Interventions
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IB1001
Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa; Study Part 2: Non-randomized, open-label evaluation of prophylaxis and on demand IB1001; Surgical Sub-study: Open-label evaluation of IB1001 during major surgery
nonacog alfa
Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
5 Years
ALL
No
Sponsors
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Medexus Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
The Hemophilia Treatment Center of Orthopaedic Hospital
Los Angeles, California, United States
Emory University School of Medicine Pediatric Hematology
Atlanta, Georgia, United States
Rush University Medical Center-Pediatric Hematology Oncology
Chicago, Illinois, United States
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States
University of Minnesota Center for Bleeding and Clotting Disorder
Minneapolis, Minnesota, United States
Hemophilia Treatment Center of Las Vegas
Las Vegas, Nevada, United States
Hemophilia and Thrombosis Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center-Houston, Gulf States Hemophilia & Thrombophilia Center
Houston, Texas, United States
Centre Regional de Traitement de l 'Hemophilie
Nantes, Loire-Atlantique, France
Hopital Edouard Herriot
Lyon, , France
Sahyadri Specialty Hospital, Deccan Gymkhana
Pune, Maharashtra, India
Jehangir Clinical Development Centre
Pune, Maharashtra, India
The National Hemophilia Center-Sheba MC
Tel Litwinsky, Ramat Gan, Israel
Ospedale di Careggi
Florence, , Italy
University of Milan
Milan, , Italy
MTZ Clinical Research
Warsaw, , Poland
Royal Free Hospital
London, England, United Kingdom
Manchester Haemophilia Comprehensive Care Manchester Royal Infirmary
Manchester, England, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Centre for Haemostasis and Thrombosis, Basingstoke and North Hampshire Foundation Trust
Basingstoke, Hampshire, United Kingdom
University Hospital of Wales Health Park
Cardiff, Wales, United Kingdom
Countries
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References
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Collins PW, Quon DVK, Makris M, Chowdary P, Kempton CL, Apte SJ, Ramanan MV, Hay CRM, Drobic B, Hua Y, Babinchak TJ, Gomperts ED. Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated haemophilia B patients. Haemophilia. 2018 Jan;24(1):104-112. doi: 10.1111/hae.13324. Epub 2017 Aug 17.
Martinowitz U, Shapiro A, Quon DV, Escobar M, Kempton C, Collins PW, Chowdary P, Makris M, Mannucci PM, Morfini M, Valentino LA, Gomperts E, Lee M. Pharmacokinetic properties of IB1001, an investigational recombinant factor IX, in patients with haemophilia B: repeat pharmacokinetic evaluation and sialylation analysis. Haemophilia. 2012 Nov;18(6):881-7. doi: 10.1111/j.1365-2516.2012.02897.x. Epub 2012 Jul 5.
Other Identifiers
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IB1001-01
Identifier Type: -
Identifier Source: org_study_id
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