PF-06741086 Multiple Dose Study in Severe Hemophilia

Pfizer

Status and phase

Completed

Phase 2

Conditions

Hemophilia A or B

Treatments

Biological: PF-06741086

Study type

Interventional

Funder types

Industry

Identifiers

NCT02974855

B7841002

2016-001885-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

27 participants in 4 patient groups

PF-06741086 (Cohort 1)

Experimental group

Treatment:

Biological: PF-06741086

PF-06741086 (Cohort 2)

Experimental group

Treatment:

Biological: PF-06741086

PF-06741086 (Cohort 3)

Experimental group

Treatment:

Biological: PF-06741086

PF-06741086 (Cohort 4)

Experimental group

Treatment:

Biological: PF-06741086

Trial documents

2

Trial contacts and locations

10

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