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PF-06741086 Multiple Dose Study in Severe Hemophilia

Last updated on March 31, 2020

FOR MORE INFORMATION
Study Location
UC Denver Hemophilia and Thrombosis Center - Pharmacy
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
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
Completed
PF-06741086 Multiple Dose Study in Severe Hemophilia

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE PF-06741086 Multiple Dose Study in Severe Hemophilia
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hemophilia A or B
Intervention  ICMJE
  • Biological: PF-06741086
    PF-06741086 subcutaneous (SC) injection
  • Biological: PF-06741086
    PF-06741086 SC injection
Study Arms  ICMJE
  • 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
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: October 22, 2018)
27
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2016)
24
Actual Study Completion Date  ICMJE December 3, 2018
Actual Primary Completion Date December 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
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 Chile,   Croatia,   Poland,   South Africa,   Switzerland,   United States
Removed Location Countries France,   Spain
 
Administrative Information
NCT Number  ICMJE NCT02974855
Other Study ID Numbers  ICMJE B7841002
2016-001885-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2019

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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