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Clotting Factor Replacement

Jivi for Hemophilia A in Children (Alfa-PROTECT Trial)

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be previously treated with FVIII concentrate(s) (plasma derived or recombinant) for a minimum of 50 exposure days (EDs) at the time of signing the informed consent
Be younger than 18 years old
Must not have
Current evidence of inhibitor to FVIII measured using the Nijmegen-modified Bethesda assay (>0.6 BU/mL) at the time of screening (central laboratory)
Any individual who received commercially available subcutaneous factor substitution therapy (emicizumab) within the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking for a better way to treat hemophilia A, a genetic disorder where the body does not create enough of a protein called clotting factor 8 (FVIII) present in the blood.

Who is the study for?
This trial is for children aged 7 to less than 12 with severe hemophilia A, who have been previously treated with clotting factor concentrates. They must not have used certain other treatments recently and should be free of inhibitors to FVIII. Participants need the ability to use an electronic diary and consent from parents.
What is being tested?
Researchers are testing BAY94-9027 (Jivi), a pegylated injectable treatment designed to replace missing clotting factor VIII in kids with severe hemophilia A. The study aims to determine its safety and how it affects the body over a period that spans up to two years.
What are the potential side effects?
Possible side effects include allergic reactions ranging from mild local symptoms like skin rashes, shortness of breath, low blood pressure, or more serious issues such as antibodies forming against the drug which could reduce its effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with FVIII for at least 50 days before signing the consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood test shows I have inhibitors to Factor VIII.
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I have not used emicizumab in the last 6 months.
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I am scheduled for a major surgery during the study period.
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I have had inhibitors to Factor VIII.
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I need medication like antihistamines to tolerate FVIII treatment.
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I have a bleeding disorder in addition to hemophilia A.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AESI (hypersensitivity and loss of efficacy) associated with the first 4 exposure days leading to discontinuation

Side effects data

From 2022 Phase 4 trial • 32 Patients • NCT04085458
16%
Upper respiratory tract infection
9%
Limb injury
9%
Arthralgia
6%
Tooth extraction
6%
Back pain
6%
Cough
6%
Epistaxis
6%
Pyrexia
3%
Fall
3%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Severe Hemophilia A Patients With Damoctocog Alfa Pegol (Jivi, BAY94-9027) Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Main study (Part A) and the extension study (Part B)Experimental Treatment1 Intervention
Part A will last for 6 months. After completing Part A participants will continue in the extension study for another 18 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Damoctocog alfa pegol (Jivi, BAY94-9027)
2019
Completed Phase 4
~40

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,274 Previous Clinical Trials
25,532,348 Total Patients Enrolled
60 Trials studying Hemophilia A
5,602 Patients Enrolled for Hemophilia A

Media Library

Damoctocog alfa pegol (Jivi, BAY94-9027) (Clotting Factor Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05147662 — Phase 3
Hemophilia A Research Study Groups: Main study (Part A) and the extension study (Part B)
Hemophilia A Clinical Trial 2023: Damoctocog alfa pegol (Jivi, BAY94-9027) Highlights & Side Effects. Trial Name: NCT05147662 — Phase 3
Damoctocog alfa pegol (Jivi, BAY94-9027) (Clotting Factor Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05147662 — Phase 3
~9 spots leftby Nov 2025
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