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

Hemophilia A Clinical Trial

Official title:

Post-marketing Investigation (PMI) to Assess Safety and Efficacy of Jivi (BAY 94-9027) Treatment in Participants With Hemophilia A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085458
• Other study ID #: 19764
• Secondary ID: 2018-003655-37
• Status: Completed
• Phase: Phase 4
• Start date: September 23, 2019
• Est. completion date: August 26, 2022

Study information

• Verified date: July 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 26, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

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.

Locations

Country	Name	City	State
Bulgaria	UMHAT Tsaritsa Joanna-ISUL EAD Sofia	Sofia
Bulgaria	MHAT Sveta Marina EAD	Varna
Denmark	Aarhus Universitetshospital, Skejby	Arhus N
Greece	LAIKO General Hospital of Athens	Athens
Italy	A.O. Pugliese-Ciaccio	Catanzaro	Calabria
Italy	A.O.U. Policlinico Umberto I	Roma	Lazio
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Lazio
Norway	Oslo Universitetssykehus HF, Rikshospitalet	Oslo
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	SP Szpital Kliniczny Nr 1	Wroclaw
Spain	Ciutat Sanitaria i Universitaria de la Vall d'Hebron	Barcelona
Spain	Hospital Universitario "La Paz"	Madrid
Spain	Hospital Universitari i Politecnic La Fe | Hematologia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Bulgaria,  Denmark,  Greece,  Italy,  Norway,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FVIII Inhibitor Development by the Nijmegen Bethesda Assay	FVIII inhibitor testing was performed using the Nijmegen-modified Bethesda assay. A positive inhibitor result was defined as a threshold of =0.6 BU/mL at the central laboratory and had to be confirmed with a second blood sample. After confirmation of the positive result, the inhibitor was to be reported as a serious adverse event (SAE).	Observed for 100 exposure days (EDs), up to 2 years
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Treatment-emergent AEs were defined as those that started after the first dose of study drug and up to 7 days after the last dose.	Observed for 100 exposure days (EDs), up to 2 years
Secondary	Development of Treatment-emergent Anti-PEG Antibodies	Anti-PEG antibody: antibody against the PEG moiety determined by enzyme-linked immunosorbent assay (ELISA). For participants with a positive result, IgM antibodies were tested.	Observed for 100 exposure days (EDs), up to 2 years
Secondary	Annualized Bleeding Rate (ABR)	ABR is number of all bleeds per individual treatment period annualized to a 1-year time interval.	Observed for 100 exposure days (EDs), up to 2 years

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