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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT00768287
First received: October 7, 2008
Last updated: January 29, 2014
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hemophilia B
Biological: IB1001 (On-Demand)
Biological: IB1001 (Prophylaxis)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

Resource links provided by NLM:


Further study details as provided by Cangene Corporation:

Primary Outcome Measures:
  • degree of hemorrhage control by treatment regimen [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: January 2009
Estimated Study Completion Date: November 2014
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IB1001 Biological: IB1001 (On-Demand)
use as needed
Biological: IB1001 (Prophylaxis)
use on a prophylaxis basis

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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: NCT00768287

  Show 23 Study Locations
Sponsors and Collaborators
Cangene Corporation
  More Information

No publications provided by Cangene Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cangene Corporation
ClinicalTrials.gov Identifier: NCT00768287     History of Changes
Other Study ID Numbers: IB1001-01
Study First Received: October 7, 2008
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on October 21, 2014