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Phase 1 Safety, Pharmacokinetics And Pharmacodynamics Study Of Recombinant Factor VIIa Variant (813d) In Adult Subjects With Hemophilia

NCT ID: NCT01439971

Last Updated: 2017-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-10-31

Brief Summary

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This study hypothesizes that the study drug, PF-05280602 (at the selected doses) will be safe to administer to subjects with severe Hemophilia A or B with or without inhibitors and will demonstrate evidence of hemostatic activity. This is supported by the preclinical findings in hemophilic animal models.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The was an ascending dose trial with one open label treatment, intervention model was sequential dose escalation.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

PF-05280602

Intervention Type BIOLOGICAL

0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose

2

Group Type EXPERIMENTAL

PF-05280602

Intervention Type BIOLOGICAL

4.5 micrograms per kilogram of PF-05280602, IV infusion, single dose

3

Group Type EXPERIMENTAL

PF-05280602

Intervention Type BIOLOGICAL

9.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

4

Group Type EXPERIMENTAL

PF-05280602

Intervention Type BIOLOGICAL

18.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

5

Group Type EXPERIMENTAL

PF-05280602

Intervention Type BIOLOGICAL

30.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

Interventions

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PF-05280602

0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose

Intervention Type BIOLOGICAL

PF-05280602

4.5 micrograms per kilogram of PF-05280602, IV infusion, single dose

Intervention Type BIOLOGICAL

PF-05280602

9.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

Intervention Type BIOLOGICAL

PF-05280602

18.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

Intervention Type BIOLOGICAL

PF-05280602

30.0 micrograms per kilogram of PF-05280602, IV infusion, single dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male subjects 18 to \<65 years old with severe hemophilia A or B with or without inhibitors to FVIII or FIX.
* Subjects is willing and able to comply with the mandatory washout periods prior to screening and prior to dosing and through 48 hours post dosing. At screening this includes a washout of FIX for 96 hours and FVIII for 72 houts. At dosing this includes a washout of FIX for 96 hours and FVIII and other hemostatic agents for 72 hours through 48 hours post dosing.
* Subjects must agree and commit to using a a highly effective method of birth control from the time of screening through four weeks after study drug administration.

Exclusion Criteria

* Presence of a bleeding disorder in addition to hemophilia A or B.
* Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin, and routine systemic corticosteroids).
* History of coronary artery disease, thrombolic disease or diagnosis of prothrombic disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Catalyst Biosciences

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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University of California San Diego Medical Center

San Diego, California, United States

Site Status

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Doernbecher Children's Hospital

Portland, Oregon, United States

Site Status

OHSU Investigational Pharmacy

Portland, Oregon, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

CTRC

Philadelphia, Pennsylvania, United States

Site Status

Penn Comprehensive Hemophilia Program - Center for Blood Disorders

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Clinical Research Unit

Brussels, , Belgium

Site Status

Semmelweis Egyetem Altalanos Orvostudomanyi Kar/ I.sz. Belgyogyaszati Klinika

Budapest, , Hungary

Site Status

Dipartimento di Medicina Clinica 1-Centro Regionale per le Malattie del Sangue

Castelfranco Veneto (TV), Italy, Italy

Site Status

Servizio Farmacia- Ospedale Castelfranco Veneto

Castelfranco Veneto - Treviso, Italy, Italy

Site Status

Servizio Farmacia Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Italy, Italy

Site Status

Farmacia Ospedaliera Ospedale San Bortolo

Vicenza, Italy, Italy

Site Status

Centro Emofilia e Trombosi "Angelo Bianchi Bonomi" U.O.S. Dipartimentale per la Diagnosi e la Terapi

Milan, , Italy

Site Status

Centro Malattie Emorragiche e Trombotiche - Ematologia

Vicenza, , Italy

Site Status

Christchurch Clinical Studies Trust

Christchurch, New Zealand, New Zealand

Site Status

Phoenix Pharma (Pty) Ltd

Port Elizabeth, Eastern Cape, South Africa

Site Status

Ege University Tip Fakultesi

Izmir, Turkey, Turkey (Türkiye)

Site Status

Royal Free Hampstead NHS Trust, Royal Free Hospital

London, , United Kingdom

Site Status

Haematology Department

London, , United Kingdom

Site Status

Central Manchester Universtiy Hospitals NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United States Belgium Hungary Italy New Zealand South Africa Turkey (Türkiye) United Kingdom

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3051001

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

Other Identifiers

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2011-002170-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B3051001

Identifier Type: -

Identifier Source: org_study_id

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