Jivi interventional PMI study to assess safety and efficacy

Phase 1

• Conditions: Hemophilia A; MedDRA version: 20.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-003655-37-DK
• Lead Sponsor: Bayer Consumer Care AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-29
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Participants must = 18 years of age inclusive, at the time of signing the informed consent
2. Participants with severe hemophilia A (FVIII: C<1%)
3. PTPs (=150 ED) on prophylaxis treatment before enrollment
4. Participants who are immunocompetent. If human immunodeficiency virus (HIV) positive, cluster of differentiation 4 (CD4)+ lymphocyte count >200/mm3
5. Participants who are willing to complete an eDiary
Male participants
6. Capable of giving signed informed consent as described in Section 10.1.3 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Any other inherited or acquired bleeding disorder in addition to Hemophilia A.
2. Platelet count < 100,000/mm3
3. The participant has a planned major surgery.
4. 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®).
5. Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer = 0.6 Bethesda unit (BU).
6. Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.
7. Creatinine > 2x upper limit of normal
8. AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified