Jivi interventional PMI study to assess safety and efficacy

Post-marketing investigation (PMI) to assess safety and efficacy of Jivi® (BAY 94-9027) treatment in patients with hemophilia A - Jivi®

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003655-37-PL

Enrollment

Registered

2019-06-14

Start date

2019-08-05

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850

Interventions

Trade Name: Jivi® Product Name: Jivi (1000 IU/vial) Product Code: BAY 94-9027 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: DAMOCTOCOG ALFA PEGOL Current Spon

Eligibility

Sex/Gender

Male

Inclusion criteria

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: C200/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 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: 1. Any other inherited or acquired bleeding disorder in addition to Hemophilia A. 2. Platelet count 2x upper limit of normal 8. AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess general safety of Jivi® safety a with specific focus on immunogenicity and inhibitor documentation in a routine clinical use of the product in at least additional 25 participants during 100 ED in order to fully comply with Guideline requirements of 200 participants observed for at least 100 ED including participants from pre-authorization studies. ;Secondary Objective: Assess clinical efficacy of Jivi;Primary end point(s): Safety: FVIII inhibitor development by the Nijmegen Bethesda assay. ;Timepoint(s) of evaluation of this end point: Continuous throughout the study.	—

Measure

Time frame

Main Objective: Assess general safety of Jivi® safety a with specific focus on immunogenicity and inhibitor documentation in a routine clinical use of the product in at least additional 25 participants during 100 ED in order to fully comply with Guideline requirements of 200 participants observed for at least 100 ED including participants from pre-authorization studies. ;Secondary Objective: Assess clinical efficacy of Jivi;Primary end point(s): Safety: FVIII inhibitor development by the Nijmegen Bethesda assay. ;Timepoint(s) of evaluation of this end point: Continuous throughout the study.

—

Secondary

Measure	Time frame
Secondary end point(s): Safety: Treatment-emergent adverse events (TEAE) Development of treatment-emergent anti-PEG antibodies Clinical Efficacy: Annualized bleeding rate (ABR) ;Timepoint(s) of evaluation of this end point: Throughout the study	—

Countries

Bulgaria, Denmark, Greece, Italy, Poland, Spain

Contacts

Public ContactBayer Clin. Trials Contact CTP Team

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026