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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768287
First Posted: October 8, 2008
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aptevo Therapeutics ( Aptevo BioTherapeutics )
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Aptevo Therapeutics ( Aptevo BioTherapeutics ):

Primary Outcome Measures:
  • degree of hemorrhage control by treatment regimen [ Time Frame: throughout the study ]

Enrollment: 77
Actual Study Start Date: January 2009
Study Completion Date: December 2016
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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768287


  Show 23 Study Locations
Sponsors and Collaborators
Aptevo BioTherapeutics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aptevo BioTherapeutics
ClinicalTrials.gov Identifier: NCT00768287     History of Changes
Other Study ID Numbers: IB1001-01
First Submitted: October 7, 2008
First Posted: October 8, 2008
Last Update Posted: June 28, 2017
Last Verified: June 2017

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