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Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia

NCT01439971 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-05-12

Study results available
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Summary

This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.

Conditions

Interventions

BIOLOGICAL

PF-05280602

0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose

BIOLOGICAL

PF-05280602

4.5 micrograms per kilogram of PF-05280602, IV infusion, single dose

BIOLOGICAL

PF-05280602

9.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

BIOLOGICAL

PF-05280602

18.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

BIOLOGICAL

PF-05280602

30.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

Sponsors & Collaborators

  • Catalyst Biosciences

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States
  • Belgium
  • Hungary
  • Italy
  • New Zealand
  • South Africa
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01439971 on ClinicalTrials.gov