You are here

A Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of PF-05280602, A Recombinant Factor VIIa Variant (813d), In Adult Subjects With Hemophilia A Or B

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
University of California San Diego medical center
San Diego, California, 92103 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male subjects 18 to inhibitors to FVIII or FIX.

- Subjects is willing and able to comply with the mandatory washout periods prior to
screening and prior to dosing and through 48 hours post dosing. At screening this
includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this
includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72
hours through 48 hours post dosing.

- Subjects must agree and commit to using a a highly effective method of birth control
from the time of screening through four weeks after study drug administration.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Presence of a bleeding disorder in addition to hemophilia A or B.

- Regular, concomitant therapy with immunomodulating drugs (eg, intravenous
immunoglobulin, and routine systemic corticosteroids).

- History of coronary artery disease, thrombolic disease or diagnosis of prothrombic
disorder.

NCT01439971
Pfizer
Completed
A Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of PF-05280602, A Recombinant Factor VIIa Variant (813d), In Adult Subjects With Hemophilia A Or B

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
An Ascending Single Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics/Pharmacodynamics Of Pf-05280602, A Recombinant Factor Viia Variant (813d), In Adult Hemophilia A And B Subjects With Or Without Inhibitors
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
The was an ascending dose trial with one open label treatment, intervention model was sequential dose escalation.

Masking: None (Open Label)
Primary Purpose: Basic Science

Hemophilia A
  • 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
  • Experimental: 1
    Intervention: Biological: PF-05280602
  • Experimental: 2
    Intervention: Biological: PF-05280602
  • Experimental: 3
    Intervention: Biological: PF-05280602
  • Experimental: 4
    Intervention: Biological: PF-05280602
  • Experimental: 5
    Intervention: Biological: PF-05280602
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
October 2015
October 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male subjects 18 to <65 years old with severe hemophilia A or B with or without inhibitors to FVIII or FIX.
  • Subjects is willing and able to comply with the mandatory washout periods prior to screening and prior to dosing and through 48 hours post dosing. At screening this includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72 hours through 48 hours post dosing.
  • Subjects must agree and commit to using a a highly effective method of birth control from the time of screening through four weeks after study drug administration.

Exclusion Criteria:

  • Presence of a bleeding disorder in addition to hemophilia A or B.
  • Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin, and routine systemic corticosteroids).
  • History of coronary artery disease, thrombolic disease or diagnosis of prothrombic disorder.
Sexes Eligible for Study: Male
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Hungary,   Italy,   New Zealand,   South Africa,   Turkey,   United Kingdom,   United States
Bulgaria
 
NCT01439971
B3051001
2011-002170-23 ( EudraCT Number )
Yes
Not Provided
Plan to Share IPD: No
Catalyst Biosciences
Catalyst Biosciences
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Catalyst Biosciences
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now