check_circleStudy Completed

Hemophilia A

Bayer Identifier:

19764

ClinicalTrials.gov Identifier:

NCT04085458

EudraCT Number:

2018-003655-37

EU CT Number:

Not Available
Study to gain more information on how safe and effective Jivi works in patients with severe hemophilia A (post-marketing investigation)

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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

  • - 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
September 2019 - August 2022
Phase
Phase 4
Could I Receive a placebo
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Completed
Oslo Universitetssykehus HF, RikshospitaletOslo, 0372, Norway
Completed
UMHAT Tsaritsa Joanna-ISUL EAD SofiaSofia, 1527, Bulgaria
Completed
LAIKO General Hospital of AthensAthens, 115 27, Greece
Completed
Hospital Universitario "La Paz"Madrid, 28046, Spain
Completed
Hospital Universitari i Politecnic La Fe | HematologiaValencia, 46026, Spain
Completed
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
A.O.U. Policlinico Umberto IRoma, 00161, Italy
Completed
A.O. Pugliese-CiaccioCatanzaro, 88100, Italy
Completed
Aarhus Universitetshospital, SkejbyArhus N, 8200, Denmark
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, 00168, Italy
Completed
Uniwersyteckie Centrum KliniczneGdansk, 80-214, Poland
Completed
SP Szpital Kliniczny Nr 1Wroclaw, 50-367, Poland

Primary Outcome

  • FVIII inhibitor development by the Nijmegen Bethesda assay
    date_rangeTime Frame:
    Up to 2 years

Secondary Outcome

  • Number of participants with treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 2 years
  • Development of treatment-emergent anti-PEG antibodies
    date_rangeTime Frame:
    Up to 2 years
  • Annualized bleeding rate (ABR)
    date_rangeTime Frame:
    Up to 2 years

Trial design

Post-marketing investigation (PMI) to assess safety and efficacy of Jivi (BAY 94-9027) treatment in participants with hemophilia A
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here to find information about studies related to Bayer Healthcare products conducted in EuropeClick here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.