NCT01542619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 21, 2017

Status Verified

March 1, 2013

Enrollment Period

3 months

First QC Date

February 26, 2012

Last Update Submit

April 19, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • The frequency of related Adverse Events (AEs) to rVIIa-FP.

    28 days

  • Number of subjects who develop inhibitors against Factor VII (FVII).

    28 days

  • Number of subjects who develop antibodies against rVIIa-FP.

    28 days

Secondary Outcomes (4)

  • Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP

    120 hours

  • Half- life (t1/2) of a single dose of rVIIa-FP

    120 hours

  • Incremental recovery (IR) of rVIIa-FP

    120 hours

  • Clearance (Cl) of a single dose of rVIIa-FP

    120 hours

Study Arms (2)

rVIIa-FP

EXPERIMENTAL
Biological: rVIIa-FP

Placebo (0.9% normal saline)

PLACEBO COMPARATOR
Biological: Placebo (0.9% normal saline)

Interventions

rVIIa-FPBIOLOGICAL

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.

rVIIa-FP
Placebo (0.9% normal saline)BIOLOGICAL

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.

Placebo (0.9% normal saline)

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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®).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phase I Unit

Berlin, Germany

Location

Related Publications (1)

  • Golor G, Bensen-Kennedy D, Haffner S, Easton R, Jung K, Moises T, Lawo JP, Joch C, Veldman A. Safety and pharmacokinetics of a recombinant fusion protein linking coagulation factor VIIa with albumin in healthy volunteers. J Thromb Haemost. 2013 Nov;11(11):1977-85. doi: 10.1111/jth.12409.

    PMID: 24112951RESULT

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Alex Veldman, M.D.

    CSL Behring

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2012

First Posted

March 2, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

April 21, 2017

Record last verified: 2013-03

Locations

DE(1)