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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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 more

Side effects data

From 2022 Phase 4 trial • 32 Patients • NCT04085458

16%

Upper respiratory tract infection

Arthralgia

Limb injury

Tooth extraction

Back pain

Cough

Epistaxis

Pyrexia

Fall

Osteoarthritis

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,945 Total Patients Enrolled

60 Trials studying Hemophilia A

5,606 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for new participants in this experiment?

"Yes, this information is available on clinicaltrials.gov. This particular trial was published on 3/23/2022 and has since been updated 11/11/2022."

Answered by AI

To the best of your knowledge, is this type of experiment novel?

"Bayer's Damoctocog alfa pegol (Jivi, BAY94-9027) has undergone 7 clinical trials since it was first introduced in 2022. The most recent study is still ongoing, recruiting patients from 25 different cities across 7 countries."

Answered by AI

Does Damoctocog alfa pegol (Jivi, BAY94-9027) put patients at risk?

"There is available data that suggests Damoctocog alfa pegol (Jivi, BAY94-9027) is safe, and it thus received a score of 3."

Answered by AI

How many participants are being allowed in this clinical trial?

"In order to carry out this experiment, 33 individuals who meet the prerequisites must be recruited. Patients have the opportunity to take part in this research from multiple hospitals, including Rush University Medical Center located in Chicago, Illinois and University Hospitals Cleveland Medical Center situated in Cleveland, Ohio."

Answered by AI

What medical conditions is Damoctocog alfa pegol (Jivi, BAY94-9027) used to treat?

"Damoctocog alfa pegol (Jivi, BAY94-9027) is most commonly used to reduce blood loss during surgery. It can also be used to effectively treat patients with conditions such as hemorrhage and hemophilia that have not responded well to other treatments."

Answered by AI

Can you please provide background on other scientific investigations that have used Damoctocog alfa pegol (Jivi, BAY94-9027)?

"Right now, there are two ongoing studies and one Phase 3 clinical trial for Damoctocog alfa pegol (Jivi, BAY94-9027). Most of these medical trials are based in Augusta, Georgia; however, 41 locations across the country are running similar investigations."

Answered by AI

Could I possibly participate in this research?

"This study is only seeking patients that have hemophilia a and are aged 7-11. The total number of participants they are looking for is 33."

Answered by AI

Does this research include individuals who are senior citizens?

"This particular clinical trial is for children aged 7 to 11. Out of the 522 total clinical trials, 141 are specifically for patients under 18 and 381 are for those over 65 years old."

Answered by AI

Are there several sites running this study in the metropolitan area?

"This trial is based in several locations, including but not limited to Rush University Medical Center (Chicago, Illinois), University Hospitals Cleveland Medical Center (Cleveland, Ohio), and UC Davis Comprehensive Cancer Center (Sacramento, California)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood

2022. "A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05147662.

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