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

Completed · Phase 1

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT01439971

Run by

Catalyst Biosciences

People needed

29

Starts

2011-12-01

Expected to finish

2015-10-01

Last updated by the study team

2017-05-12

Who can join

Age: 18 and older, up to 64. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California San Diego Medical Center — San Diego, California, United States
• New Haven Clinical Research Unit — New Haven, Connecticut, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Doernbecher Children's Hospital — Portland, Oregon, United States
• OHSU Investigational Pharmacy — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• CTRC — Philadelphia, Pennsylvania, United States
• Penn Comprehensive Hemophilia Program - Center for Blood Disorders — Philadelphia, Pennsylvania, United States
• Pfizer Clinical Research Unit — Brussels, Belgium
• Semmelweis Egyetem Altalanos Orvostudomanyi Kar/ I.sz. Belgyogyaszati Klinika — Budapest, Hungary
• Dipartimento di Medicina Clinica 1-Centro Regionale per le Malattie del Sangue — Castelfranco Veneto (TV), Italy, Italy
• Servizio Farmacia- Ospedale Castelfranco Veneto — Castelfranco Veneto - Treviso, Italy, Italy
• Servizio Farmacia Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan, Italy, Italy
• Farmacia Ospedaliera Ospedale San Bortolo — Vicenza, Italy, Italy
• Centro Emofilia e Trombosi "Angelo Bianchi Bonomi" U.O.S. Dipartimentale per la Diagnosi e la Terapi — Milan, Italy
• Centro Malattie Emorragiche e Trombotiche - Ematologia — Vicenza, Italy
• Christchurch Clinical Studies Trust — Christchurch, New Zealand, New Zealand
• Phoenix Pharma (Pty) Ltd — Port Elizabeth, Eastern Cape, South Africa
• Ege University Tip Fakultesi — Izmir, Turkey, Turkey (Türkiye)
• Royal Free Hampstead NHS Trust, Royal Free Hospital — London, United Kingdom
• Haematology Department — London, United Kingdom
• Central Manchester Universtiy Hospitals NHS Foundation Trust — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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