Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)

PHASE4CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 23, 2019

Primary Completion Date

May 20, 2022

Study Completion Date

August 26, 2022

Conditions
Hemophilia A
Interventions
DRUG

Damoctocog alfa pegol (Jivi, BAY94-9027)

The recommended starting dose is every 5 days treatment (45 IU/kg)- An assessment of response to treatment will be performed at the next scheduled visit after 10-15 ED (8-10 weeks). Participants may be assigned to different dosing regimens (every 7 days or 2x/week) or continue with every 5 days regimen, according to individual bleeding tendency and needs at investigator's discretion.

Trial Locations (13)

1527

UMHAT Tsaritsa Joanna-ISUL EAD Sofia, Sofia

8200

Aarhus Universitetshospital, Skejby, Arhus N

9010

MHAT Sveta Marina EAD, Varna

28046

"Hospital Universitario La Paz", Madrid

88100

A.O. Pugliese-Ciaccio, Catanzaro

115 27

LAIKO General Hospital of Athens, Athens

00161

A.O.U. Policlinico Umberto I, Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

0372

Oslo Universitetssykehus HF, Rikshospitalet, Oslo

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

50-367

SP Szpital Kliniczny Nr 1, Wroclaw

08035

Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona

Unknown

"Hospital Universitari i Politecnic La Fe , Hematologia"

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY