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A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01542619
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Brief Summary:
This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo.

Condition or disease Intervention/treatment Phase
Healthy Biological: rVIIa-FP Biological: Placebo (0.9% normal saline) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Single Center, 5 Cohort Dose Escalation Trial to Investigate Safety and Pharmacokinetics of rVIIa-FP (CSL689) in Comparison to Placebo in Healthy Male Human Volunteers
Study Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: rVIIa-FP Biological: rVIIa-FP
Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered.
Placebo Comparator: Placebo (0.9% normal saline) Biological: Placebo (0.9% normal saline)
Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered.



Primary Outcome Measures :
  1. The frequency of related Adverse Events (AEs) to rVIIa-FP. [ Time Frame: 28 days ]
  2. Number of subjects who develop inhibitors against Factor VII (FVII). [ Time Frame: 28 days ]
  3. Number of subjects who develop antibodies against rVIIa-FP. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP [ Time Frame: 120 hours ]
  2. Half- life (t1/2) of a single dose of rVIIa-FP [ Time Frame: 120 hours ]
  3. Incremental recovery (IR) of rVIIa-FP [ Time Frame: 120 hours ]
  4. Clearance (Cl) of a single dose of rVIIa-FP [ Time Frame: 120 hours ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects between 18 and 35 years of age, both inclusive.
  • Body weight between 50.0 and 100.0 kg, both inclusive.
  • Body mass index (BMI) between 18.0 and 29.9 kg/m2, both inclusive.
  • Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria:

  • Subjects at increased cardiovascular risk.
  • Any clinical sign or known history of atherosclerosis or thromboembolic events.
  • A subject considered at high risk of thromboembolic events confirmed either from history or by thrombophilia screening test.
  • Subjects with significant elevation of cholesterol level.
  • Renal dysfunction.
  • Overt bleeding.
  • Smokers with positive cotinine test at screening.
  • Participation in any other trial investigating a procoagulant within the last six months prior to screening.
  • Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
  • Contraindications to Warfarin (Coumadin®).

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): NCT01542619


Locations
Germany
Phase I Unit
Berlin, Germany
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Alex Veldman, M.D. CSL Behring