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 5, 2019

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 Representative

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 city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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

Condition  ICMJE Hemophilia A
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
29
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2011)
36
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion DateOctober 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Hungary,   Italy,   New Zealand,   South Africa,   Turkey,   United Kingdom,   United States
Removed Location CountriesBulgaria
 
Administrative Information
NCT Number  ICMJE NCT01439971
Other Study ID Numbers  ICMJE B3051001
2011-002170-23 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible PartyCatalyst Biosciences
Study Sponsor  ICMJE Catalyst Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountCatalyst Biosciences
Verification DateApril 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now