PF-06741086 Long-term Treatment in Severe Hemophilia

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NCT03363321

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Study Location
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2913, South Africa
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By email

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[email protected]

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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
12-74 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.

- 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


- Concomitant treatment with activated prothrombin complex concentrate

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Hemophilia A or BPF-06741086 Long-term Treatment in Severe Hemophilia
NCT03363321
  1. Johannesburg, Gauteng
  2. Aurora, Colorado
  3. Aurora, Colorado
  4. Campinas, SAO Paulo
  5. Rio de Janeiro,
  6. Santiago, Puente ALTO
  7. Zagreb,
  8. Gdansk,
  9. Gdansk,
  10. Port Elizabeth, Eastern CAPE
  11. Johannesburg, Gauteng
  12. Zurich,
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12 Years+
years
MULTIPLE SITES
Hemophilia A or BPF-06741086 Multiple Dose Study in Severe Hemophilia
NCT02974855
  1. Aurora, Colorado
  2. Aurora, Colorado
  3. Chicago, Illinois
  4. Chicago, Illinois
  5. Santiago,
  6. Zagreb,
  7. Gdansk,
  8. Port Elizabeth, Eastern CAPE
  9. Johannesburg, Gauteng
  10. Zurich,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE PF-06741086 Long-term Treatment in Severe Hemophilia
Official Title  ICMJE A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA
Brief Summary 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.
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 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
  • Experimental: PF-06741086 (Cohort 5)
    Intervention: Biological: PF-06741086
  • Experimental: PF-06741086 (Cohort 6)
    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: September 8, 2020)		20
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2017)		36
Actual Study Completion Date  ICMJE August 5, 2020
Actual Primary Completion Date August 5, 2020   (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%)
  • 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.
  • 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
  • Concomitant treatment with activated prothrombin complex concentrate
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 12 Years to 74 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Chile,   Croatia,   Poland,   South Africa,   Switzerland,   United States
Removed Location Countries France,   Spain
 
Administrative Information
NCT Number  ICMJE NCT03363321
Other Study ID Numbers  ICMJE B7841003
2017-001255-31 ( 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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP