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PF-06741086 Long-term Treatment in Severe Hemophilia

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NCT03363321

Last updated on November 2, 2018
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FOR MORE INFORMATION
Study Location
UC Denver Hemophilia and Thrombosis Center
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
12-65 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%)

- Subjects enrolled as Factor VIII or Factor IX inhibitor patients must have a positive
inhibitor test result (above the upper limit of normal) at the local laboratory and
must receive a bypass agent as primary treatment for bleeding episodes.

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

- Concomitant treatment with activated prothrombin complex concentrate

NCT03363321
Pfizer
Recruiting
PF-06741086 Long-term Treatment in Severe Hemophilia

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[email protected]

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PF-06741086 Long-term Treatment in Severe Hemophilia
A Multicenter, Open-label Study To Evaluate The Long-term Safety, Tolerability And Efficacy Of Subcutaneous Or Intravenous PF-06741086 In Subjects With Severe Hemophilia
This study is designed to evaluate the safety, tolerability and efficacy of long-term treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.
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 injection
  • 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
  • Experimental: PF-06741086 (Cohort 5)
    Intervention: Biological: PF-06741086
  • Experimental: PF-06741086 (Cohort 6)
    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.
 
Not yet recruiting
36
June 12, 2019
June 12, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe hemophilia A or B (Factor VIII or Factor IX activity ? 1%)
  • 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
  • Detectable or documented history of inhibitors against Factor VIII or Factor IX during the 12-month period prior to screening
  • Concomitant treatment with rFVIIa or activated prothrombin complex concentrate
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years to 65 Years   (Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03363321
B7841003
2017-001255-31 ( 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
January 2018

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.

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1-800-718-1021

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