Trial Condition(s):

Hemophilia A

Study to gain more information on how safe and effective Jivi works in patients with severe hemophila A (post-marketing investigation)

Bayer Identifier:

19764

ClinicalTrials.gov Identifier:

NCT04085458

EudraCT Number:

2018-003655-37

Study Completed

Trial Purpose

The goal of this study is to give gather more information on how safe and well Jivi works in patients with severe hemophilia A. Jivi has been approved by various regulatory agencies, including the FDA, Health Canada, Japanese Health Authority and the European Medicinal Agency. 25 patients will be enrolled and will stay for 1 to 2 years in this study depending on their treatment frequency. Researcher will monitor during the course of the study whether patients are developing antibodies (a protein made by the body in response to the drug) affecting the effectiveness of Jivi. In addition information on bleedings and patient’s wellbeing will be collected.

Inclusion Criteria
- Participants must ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Participants with severe hemophilia A (FVIII: C<1%)
- PTPs (Previously treated patients) (≥150 ED (Exposure day)) on prophylaxis treatment before enrollment
- Participants who are immunocompetent. If human immunodeficiency virus (HIV)
positive, cluster of differentiation 4 (CD4)+ lymphocyte count >200/mm*3
- Participants who are willing to complete an eDiary
- Male participants
- Capable of giving signed informed consent
Exclusion Criteria
- Any other inherited or acquired bleeding disorder in addition to Hemophilia A.
- Platelet count < 100,000/mm*3
- Creatinine > 2x upper limit of normal
- AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)
- The participant has a planned major surgery. 
- The participant is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of signing informed consent or previous treatment in a clinical phase III study with BAY 94-9027 (now marketed as Jivi).
- Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer ≥ 0.6 Bethesda unit (BU).
- Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.

Trial Summary

Enrollment Goal
32
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

MHAT Sveta Marina EAD

Varna, Bulgaria, 9010

Status
Completed
 
Locations

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, Norway, 0372

Status
Completed
 
Locations

UMHAT Tsaritsa Joanna-ISUL EAD Sofia

Sofia, Bulgaria, 1527

Status
Completed
 
Locations

LAIKO General Hospital of Athens

Athens, Greece, 115 27

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

Hospital Universitari i Politecnic La Fe | Hematologia

Valencia, Spain, 46026

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

A.O.U. Policlinico Umberto I

Roma, Italy, 00161

Status
Completed
 
Locations

A.O. Pugliese-Ciaccio

Catanzaro, Italy, 88100

Status
Completed
 
Locations

Aarhus Universitetshospital, Skejby

Arhus N, Denmark, 8200

Status
Completed
 
Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-214

Status
Completed
 
Locations

SP Szpital Kliniczny Nr 1

Wroclaw, Poland, 50-367

Status
Completed
 

Trial Design