NCT01486927 - An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A | Biotech Hunter

Enrollment

175

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions

Hemophilia A

Interventions

BIOLOGICAL

rVIII-SingleChain

In Part 1 of the study, subjects received a single intravenous infusion of 50 IU/kg recombinant, single-chain coagulation factor VIII (rVIII-SingleChain) preceded by a 4-day washout period. In Parts 2 and 3 of the study, subjects received repeat injections of rVIII-SingleChain either as an on-demand or prophylaxis regimen at a dose and frequency determined by their study doctor. Subjects participating in the Part 3 PK analyses received a single infusion of 50 IU/kg rVIII-SingleChain and a repeat dose of the same strength of rVIII-SingleChain after 3 to 6 months. Subjects from Parts 2 and 3 participating in the surgical substudy received an individualized dose regimen of rVIII-SingleChain, based on the type of surgery and the clinical status of the subject.

BIOLOGICAL

Octocog alfa

In Part 1 of the study, subjects received a single intravenous infusion of 50 IU/kg of octocog alfa preceded by a 4-day washout period. Octocog alfa is the international nonproprietary name (INN) for recombinant human coagulation factor VIII.

Trial Locations (56)

1090

Study Site, Vienna

2193

Study Site, Johannesburg

6000

Study Site, Cebu City

7295

Study Site, Cape Town

8000

Study Site, Davao City

8036

Study Site, Graz

10126

Study Site, Torino

10249

Study Site, Berlin

13353

Study Site, Berlin

20095

Study Site, Hamburg

20122

Study Site, Milan

30159

Study Site, Hanover

33136

Study Site, Miami

35123

Study Site, Padua

35128

Study Site, Padua

35392

Study Site, Giessen

46026

Study Site, Valencia

49102

Study Site, Dnipropetrovsk

50134

Study Site, Florence

50400

Study Site, Kuala Lumpur

53127

Study Site, Bonn

53226

Study Site, Milwaukee

69123

Study Site, Heidelberg

70112

Study Site, New Orleans

77030

Study Site, Houston

79044

Study Site, Lviv

80045

Study Site, Aurora

92103

Study Site, San Diego

95817

Study Site, Sacramento

650066

Study Site, Kemerovo

656038

Study Site, Barnaul

830045

Study Site, Donetsk

06106

Study Site, Hartford

60612-3833

Study Site, Chicago

WA 6009

Study Site, Nedlands

WA 6000

Study Site, Perth

E2L 4L2

Study Site, New Brunswick

500 05

Study Site, Hradec Králové

H-4032

Study Site, Debrecen

Unknown

Study Site, Kashihara, Nara

Study Site, Kitakyushu, Fukuoka

Study Site, Nishinomiya, Hyogo

Study Site, Saitama

Study Site, Suginami-ku, Tokyo

Study Site, Beirut

Study Site, A Coruña

Study Site, Barcelona

466-85660

Study Site, Nagoya

710-8602

Study Site, Okayama

160-0023

Study Site, Tokyo

3584 CX

Study Site, Utrecht

50-367

Study Site, Wroclaw

80-952

Study Site, Gdansk

31-501

Study Site, Krakow

011026

Study Site, Bucharest

NW3 2QG

Study Site, London