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

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Hemophilia A
Interventions
BIOLOGICAL

PF-05280602

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

BIOLOGICAL

PF-05280602

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

BIOLOGICAL

PF-05280602

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

BIOLOGICAL

PF-05280602

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

BIOLOGICAL

PF-05280602

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

Trial Locations (23)

1083

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

6001

Phoenix Pharma (Pty) Ltd, Port Elizabeth

19104

CTRC, Philadelphia

Penn Comprehensive Hemophilia Program - Center for Blood Disorders, Philadelphia

20122

Servizio Farmacia Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan

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

31033

Dipartimento di Medicina Clinica 1-Centro Regionale per le Malattie del Sangue, Castelfranco Veneto (TV)

Servizio Farmacia- Ospedale Castelfranco Veneto, Castelfranco Veneto - Treviso

35100

Ege University Tip Fakultesi, Izmir

36100

Farmacia Ospedaliera Ospedale San Bortolo, Vicenza

Centro Malattie Emorragiche e Trombotiche - Ematologia, Vicenza

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60612

Rush University Medical Center, Chicago

97239

Doernbecher Children's Hospital, Portland

OHSU Investigational Pharmacy, Portland

Oregon Health & Science University, Portland

92103-8651

University of California San Diego Medical Center, San Diego

06511

New Haven Clinical Research Unit, New Haven

B-1070

Pfizer Clinical Research Unit, Brussels

08011

Christchurch Clinical Studies Trust, Christchurch

NW3 2QG

Royal Free Hampstead NHS Trust, Royal Free Hospital, London

W12 0HS

Haematology Department, London

M13 9WL

Central Manchester Universtiy Hospitals NHS Foundation Trust, Manchester

Sponsors
All Listed Sponsors
lead

Catalyst Biosciences

INDUSTRY