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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Alfa-PROTECT 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.Check my eligibility
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.See study design
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.
Alfa-PROTECT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with FVIII for at least 50 days before signing the consent.
Alfa-PROTECT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AESI (hypersensitivity and loss of efficacy) associated with the first 4 exposure days leading to discontinuation
Secondary outcome measures
Adverse drug reactions (ADRs)
Annualized bleeding rate (ABR)
Anti-drug antibody (ADA) development
+3 moreSide effects data
From 2022 Phase 4 trial • 32 Patients • NCT0408545816%
Upper respiratory tract infection
9%
Arthralgia
9%
Limb injury
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
Alfa-PROTECT 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
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Who is running the clinical trial?
BayerLead Sponsor
2,247 Previous Clinical Trials
25,333,378 Total Patients Enrolled
60 Trials studying Hemophilia A
5,606 Patients Enrolled for Hemophilia A
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a major surgery during the study period.I haven't taken chemotherapy, immune drugs (except for HIV treatment), or long-term steroids in the last 3 months.I am willing and able to learn how to use an electronic diary for the study.I need medication like antihistamines to tolerate FVIII treatment.My blood test shows I have inhibitors to Factor VIII.I have not used emicizumab in the last 6 months.I have been treated with FVIII for at least 50 days before signing the consent.I have had inhibitors to Factor VIII.I understand the study and if I'm a minor, my parent has signed the consent.I have a bleeding disorder in addition to hemophilia A.
Research Study Groups:
This trial has the following groups:- Group 1: Main study (Part A) and the extension study (Part B)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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