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PF-06741086 Multiple Dose Study in Severe Hemophilia

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NCT02974855

Last updated on May 22, 2018
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FOR MORE INFORMATION
Study Location
UC Denver Hemophilia and Thrombosis Center - Pharmacy
Aurora, Colorado, 80045 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A or B
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

- Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%), including patients
with inhibitors to Factor VIII or Factor IX

- Episodic (on-demand) treatment regimen prior to screening

- At least 6 acute bleeding episodes during the 6-month period prior to screening

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

- Known coronary artery, thrombotic, or ischemic disease

- Currently receiving treatment for acute bleeding episodes with APCC and cannot
substitute treatment with rFVIIa

NCT02974855
Pfizer
Recruiting
PF-06741086 Multiple Dose Study in Severe Hemophilia

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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PF-06741086 Multiple Dose Study in Severe Hemophilia
A Multicenter, Open-label, Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Efficacy Of Subcutaneous Or Intravenous Pf-06741086 In Subjects With Severe Hemophilia
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of PF-06741086 in subjects with severe hemophilia.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hemophilia A or B
  • Biological: PF-06741086
    PF-06741086 subcutaneous (SC) injection
  • Biological: PF-06741086
    PF-06741086 SC injection
  • Biological: PF-06741086
    PF-06741086 intravenous (IV) infusion
  • Experimental: PF-06741086 (Cohort 1)
    Intervention: Biological: PF-06741086
  • Experimental: PF-06741086 (Cohort 2)
    Intervention: Biological: PF-06741086
  • Experimental: PF-06741086 (Cohort 3)
    Intervention: Biological: PF-06741086
  • Experimental: PF-06741086 (Cohort 4)
    Intervention: Biological: PF-06741086
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
November 25, 2018
November 25, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe hemophilia A or B (Factor VIII or Factor IX activity ? 1%), including patients with inhibitors to Factor VIII or Factor IX
  • Episodic (on-demand) treatment regimen prior to screening
  • At least 6 acute bleeding episodes during the 6-month period prior to screening

Exclusion Criteria:

  • Known coronary artery, thrombotic, or ischemic disease
  • Currently receiving treatment for acute bleeding episodes with APCC and cannot substitute treatment with rFVIIa
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years to 64 Years   (Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Chile,   France,   Poland,   South Africa,   Spain,   United States
 
 
NCT02974855
B7841002
2016-001885-27 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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