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PF-06741086 Multiple Dose Study in Severe Hemophilia

NCT ID: NCT02974855

Last Updated: 2019-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2018-12-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A or B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PF-06741086 (Cohort 1)

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086 subcutaneous (SC) injection

PF-06741086 (Cohort 2)

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086 SC injection

PF-06741086 (Cohort 3)

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086 SC injection

PF-06741086 (Cohort 4)

Group Type EXPERIMENTAL

PF-06741086

Intervention Type BIOLOGICAL

PF-06741086 SC injection

Interventions

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PF-06741086

PF-06741086 subcutaneous (SC) injection

Intervention Type BIOLOGICAL

PF-06741086

PF-06741086 SC injection

Intervention Type BIOLOGICAL

PF-06741086

PF-06741086 SC injection

Intervention Type BIOLOGICAL

PF-06741086

PF-06741086 SC injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UC Denver Hemophilia and Thrombosis Center - Pharmacy

Aurora, Colorado, United States

Site Status

UC Denver Hemophilia and Thrombosis Center

Aurora, Colorado, United States

Site Status

Pharmacy

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Hospital Dr. Sotero del Rio

Santiago, , Chile

Site Status

Klinicki bolnicki centar Zagreb

Zagreb, , Croatia

Site Status

Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Site Status

Phoenix Pharma (Pty) Ltd

Port Elizabeth, Eastern Cape, South Africa

Site Status

Haemophilia Comprehensive Care Centre

Johannesburg, Gauteng, South Africa

Site Status

UniversitatsSpital Zurich, Klinik fur Hamatologie

Zurich, , Switzerland

Site Status

Countries

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United States Chile Croatia Poland South Africa Switzerland

References

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Mahlangu JN, Lamas JL, Morales JC, Malan DR, Salek SZ, Wang M, Boggio LN, Hegemann I, Mital A, Cardinal M, Zhu T, Sun P, Arkin S. A phase 1b/2 clinical study of marstacimab, targeting human tissue factor pathway inhibitor, in haemophilia. Br J Haematol. 2023 Jan;200(2):229-239. doi: 10.1111/bjh.18420. Epub 2022 Aug 23.

Reference Type DERIVED
PMID: 35999026 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7841002

To obtain contact information for a study center near you, click here.

Other Identifiers

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2016-001885-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7841002

Identifier Type: -

Identifier Source: org_study_id

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