A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B (rhFVIIa)
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ClinicalTrials.gov Identifier: NCT01708564 |
Recruitment Status :
Completed
First Posted : October 17, 2012
Last Update Posted : July 30, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemophilia | Biological: rhFVIIa | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | 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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
10 patients administered a single low dose of rhFVIIa
|
Biological: rhFVIIa
Patients will be administered low, intermediate and high doses of rhFVIIa
Other Name: Coagulation Factor VIIa (Recombinant) |
Experimental: Cohort 2
10 patients administered a single intermediate dose of rhFVIIa
|
Biological: rhFVIIa
Patients will be administered low, intermediate and high doses of rhFVIIa
Other Name: Coagulation Factor VIIa (Recombinant) |
Experimental: Cohort 3
10 patients administered a single high dose of rhFVIIa
|
Biological: rhFVIIa
Patients will be administered low, intermediate and high doses of rhFVIIa
Other Name: Coagulation Factor VIIa (Recombinant) |
- Factor VIIa concentration in patient plasma as measured by FVIIa PK and PD assays [ Time Frame: Up to 36 hours of dosing ]
- Incidence of patients with treatment emergent adverse events [ Time Frame: Up to 28 days after dosing ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- be male with a diagnosis of moderate or severe congenital hemophilia A and/or B (with or without inhibitors)
- be 18 years or older, up to and including 75 years of age
- be capable of understanding and willing to comply with the conditions of the protocol
- have read, understood and provided written informed consent
Exclusion Criteria:
- have any coagulation disorder other than hemophilia A or B
- have a body weight >105 kg (231 lb)
- 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)
- have a known allergy or hypersensitivity to rabbits
- have platelet count <100,000/mL
- have had within one month prior to first administration of the study drug in this study a major surgical procedure (e.g. orthopedic, abdominal)
- 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
- have received a Factor VII or FVIIa containing product (either plasma derived or recombinant) within 72 hours prior to any study drug administration
- 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
- 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)
- 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)
- use any anticoagulant for arterial/venous obstructions and/or atrial fibrillation within 7 days prior to first study drug administration
- have an active malignancy (those with non-melanoma skin cancer are allowed)
- 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

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): NCT01708564
United States, California | |
UC Davis Health System Internal Medicine: Hematology & Oncology | |
Sacramento, California, United States, 95817 | |
United States, Illinois | |
RUSH Hemophilia & Thrombophilia Center | |
Chicago, Illinois, United States, 60612 | |
Netherlands | |
Centre for Human Drug Research | |
Leiden, Netherlands |
Study Director: | Johan Frieling, MD,PhD | rEVO Biologics |
Responsible Party: | rEVO Biologics |
ClinicalTrials.gov Identifier: | NCT01708564 |
Other Study ID Numbers: |
GTC-FVIIa-005-11 2012-002285-13 ( EudraCT Number ) |
First Posted: | October 17, 2012 Key Record Dates |
Last Update Posted: | July 30, 2013 |
Last Verified: | July 2013 |
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |