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A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B (rhFVIIa)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rEVO Biologics
ClinicalTrials.gov Identifier:
NCT01708564
First received: October 15, 2012
Last updated: July 29, 2013
Last verified: July 2013

October 15, 2012
July 29, 2013
October 2012
June 2013   (final data collection date for primary outcome measure)
Factor VIIa concentration in patient plasma as measured by FVIIa PK and PD assays [ Time Frame: Up to 36 hours of dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01708564 on ClinicalTrials.gov Archive Site
Incidence of patients with treatment emergent adverse events [ Time Frame: Up to 28 days after dosing ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B
A Phase 1b, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients

This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose levels. The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with rhFVIIa.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hemophilia
Biological: rhFVIIa
Patients will be administered low, intermediate and high doses of rhFVIIa
Other Name: Coagulation Factor VIIa (Recombinant)
  • Experimental: Cohort 1
    10 patients administered a single low dose of rhFVIIa
    Intervention: Biological: rhFVIIa
  • Experimental: Cohort 2
    10 patients administered a single intermediate dose of rhFVIIa
    Intervention: Biological: rhFVIIa
  • Experimental: Cohort 3
    10 patients administered a single high dose of rhFVIIa
    Intervention: Biological: rhFVIIa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. be male with a diagnosis of moderate or severe congenital hemophilia A and/or B (with or without inhibitors)
  2. be 18 years or older, up to and including 75 years of age
  3. be capable of understanding and willing to comply with the conditions of the protocol
  4. have read, understood and provided written informed consent

Exclusion Criteria:

  1. have any coagulation disorder other than hemophilia A or B
  2. have a body weight >105 kg (231 lb)
  3. be immuno-suppressed (i.e., the patient should not receive systemic immunosuppressive medication <30 days prior to enrollment, CD4 counts at screening should be >200/µl)
  4. have a known allergy or hypersensitivity to rabbits
  5. have platelet count <100,000/mL
  6. have had within one month prior to first administration of the study drug in this study a major surgical procedure (e.g. orthopedic, abdominal)
  7. have an active, ongoing bleeding for which the patient is being treated, or treatment for a bleeding was stopped within 24 hours of the time of study drug administration
  8. have received a Factor VII or FVIIa containing product (either plasma derived or recombinant) within 72 hours prior to any study drug administration
  9. have received an investigational drug within 30 days of the first study drug administration, or is expected to receive such drug during participation in this study
  10. have a clinically relevant hepatic (hepatic enzymes >3 times the upper limit of normal) and/or renal impairment (creatinine >2 times the upper limit of normal)
  11. have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, deep venous thrombosis or pulmonary embolism) within 2 years prior to first dose of study drug, have an arterial stent in place or have clinically significant atherosclerotic disease (e.g., angina pectoris, peripheral vascular disease)
  12. use any anticoagulant for arterial/venous obstructions and/or atrial fibrillation within 7 days prior to first study drug administration
  13. have an active malignancy (those with non-melanoma skin cancer are allowed)
  14. have any life-threatening disease or other disease or condition which, according to the investigator's judgment, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
NCT01708564
GTC-FVIIa-005-11, 2012-002285-13
Yes
rEVO Biologics
rEVO Biologics
Not Provided
Study Director: Johan Frieling, MD,PhD rEVO Biologics
rEVO Biologics
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP