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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-23

Study Completion Date

2022-08-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Severe hemophilia A patients

Prophylactic treatment regimens should be guided by clinical judgement based on individual patient characteristics and treatment response.

Group Type OTHER

Damoctocog alfa pegol (Jivi, BAY94-9027)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No