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Clotting Factor Replacement

Prophylactic FVIII Therapy for Hemophilia A (PREDICT Trial)

Q: Has there ever been a similar research project conducted before?

Since its initial research in 2022, Damoctocog alfa-pegol (Jivi, BAY94-9027) has undergone trials sponsored by Bayer. Their first trial involved 33 participants and granted the drug Phase 3 approval. Nowadays, there are two active studies with 25 cities across 7 countries recruiting patients for treatment.

Q: How many North American locations are currently administering this investigation?

Currently, 7 medical centres are hosting this trial. These locations include Chicago, Atlanta and Los Angeles as well as other cities. To reduce your need for travel during the study, it is prudent to select a clinic nearby you if enrolling in the study.

Q: How many individuals have enrolled in this clinical examination?

Affirmative. The clinical trial's details hosted on the website, clinicaltrials.gov, reveal that is it currently seeking recruits at this time; with initial posting occurring July 28th 2022 and most recent update being November 8th 2022. 70 individuals need to be enrolled from 7 separate medical centres.

Q: Has Damoctocog alfa-pegol (Jivi, BAY94-9027) been tested in prior research initiatives?

As of now, two investigations into Damoctocog alfa-pegol (Jivi, BAY94-9027) are being conducted with one in its third phase. Most trials for this drug take place in Augusta, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a> though 41 other research sites exist across the USA.

Q: What medical purpose is Damoctocog alfa-pegol (Jivi, BAY94-9027) typically prescribed for?

Damoctocog alfa-pegol (Jivi, BAY94-9027) is the most frequently prescribed medication to reduce perioperative blood loss. Similarly, it has been seen as effective in managing hemorrhage and hemophilia among previously treated patients.

Q: Is this trial currently accepting new participants?

Per clinicaltrials.gov, this medical research is currently in need of volunteers and has been since July 28th 2022. The trial was most recently updated on November 8th 2022.

Q: What safety measures have been taken to ensure the efficacy of Damoctocog alfa-pegol (Jivi, BAY94-9027) when utilized by patients?

Data collected on the safety profile of Damoctocog alfa-pegol (Jivi, BAY94-9027) has been deemed sufficient to classify it as a 3 due its Phase 4 trial status - indicating that this therapy is approved.

Phase 4

Recruiting

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 ≥ 12 years of age inclusive, at the time of signing the informed consent/assent.

Previously treated patients (≥ 150 EDs) with congenital hemophilia A.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

PREDICT Trial Summary

This trial is studying a new way to treat people with hemophilia A by looking at how well a new scoring approach works to select a treatment plan for the prevention of bleeding.

Who is the study for?

This trial is for individuals aged 12 and older with Hemophilia A, who have been on a stable dose of standard half-life FVIII products for at least a year. They must not have current FVIII inhibitors or other bleeding disorders, and if HIV positive, they need a CD4 count over 200/mm^3. Participants should be able to maintain an electronic diary and adhere to the study's treatment plan.Check my eligibility

What is being tested?

The trial tests Jivi (damoctocog alfa pegol), an extended half-life product for Hemophilia A that requires less frequent injections than standard treatments. It aims to determine how well a new scoring approach can guide individualized prophylaxis plans based on risk factors like bleeding history and physical activity.See study design

What are the potential side effects?

Possible side effects include reactions related to the injection site, headaches, fever, nausea, joint pain or swelling due to bleeds despite treatment. As with any intravenous medication, there may also be risks of allergic reactions.

PREDICT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 12 years old or older and can consent to participate.

Select...

I have hemophilia A and have been treated more than 150 times.

PREDICT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Occurrence of favorable outcome on the score selected dosing regimen

Secondary outcome measures

ABR (total, joint, spontaneous)

Change in Haemophilia Quality of Life Questionnaire (Haem-A-QoL or Haemo-QoL)

Change in the frequency of pre-study SHL treatment to the frequency of Jivi administration (infusions/month)

+7 more

Side effects data

From 2015 Phase 4 trial • 303 Patients • NCT01064284

17%

Pyrexia

12%

Nasopharyngitis

Cough

Upper respiratory tract infection

Viral infection

Vomiting

Diarrhoea

Bronchitis

Anaemia

Head Injury

Subcutaneous haematoma

Pharyngitis

Haemorrhage intracranial

Haematemesis

Haemorrhage

Nausea

Haemorrhagic anaemia

Hemiparesis

Hemiplegia

Hypersomnia

Lymphadenopathy

Pancytopenia

Road traffic accident

Seizure

Skin haemorrhage

Speech disorder developmental

Urinary tract infection

Vessel puncture site haemorrhage

Haemarthrosis

Muscle haemorrhage

Subdural haematoma

Abdominal wall haemorrhage

Cerebral haemorrhage

Circumcision

Epidural Haemorrage

100%

80%

60%

40%

20%

Study treatment Arm

pd vWF/FVIII

rFVIII

PREDICT Trial Design

1Treatment groups

Experimental Treatment

Group I: Damoctocog alfa-pegol prophylaxis regimensExperimental Treatment1 Intervention

Prophylaxis regimens: All participants will begin with prophylaxis 2x/week (40 IU/kg/dose (recommended maximum dose 6,000 IU)) Participants with a high risk score (> 4) continue on prophylaxis 2x/week (40 IU/kg/dose). Participants with a medium risk score (2 to 4) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose). Participants with a low risk score (< 2) will switch after 4 weeks to prophylaxis Q5D (50 IU/kg/dose) and then after 4 weeks to a less frequent (e.g. Q7D) regimen (60 IU/kg/dose).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,237 Previous Clinical Trials

25,326,953 Total Patients Enrolled

60 Trials studying Hemophilia A

5,614 Patients Enrolled for Hemophilia A

Media Library

Damoctocog alfa-pegol (Jivi, BAY94-9027) (Clotting Factor Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05036278 — Phase 4

Hemophilia A Research Study Groups: Damoctocog alfa-pegol prophylaxis regimens

Hemophilia A Clinical Trial 2023: Damoctocog alfa-pegol (Jivi, BAY94-9027) Highlights & Side Effects. Trial Name: NCT05036278 — Phase 4

Damoctocog alfa-pegol (Jivi, BAY94-9027) (Clotting Factor Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036278 — Phase 4

Frequently Asked Questions

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

Has there ever been a similar research project conducted before?

"Since its initial research in 2022, Damoctocog alfa-pegol (Jivi, BAY94-9027) has undergone trials sponsored by Bayer. Their first trial involved 33 participants and granted the drug Phase 3 approval. Nowadays, there are two active studies with 25 cities across 7 countries recruiting patients for treatment."

Answered by AI

How many North American locations are currently administering this investigation?

"Currently, 7 medical centres are hosting this trial. These locations include Chicago, Atlanta and Los Angeles as well as other cities. To reduce your need for travel during the study, it is prudent to select a clinic nearby you if enrolling in the study."

Answered by AI

How many individuals have enrolled in this clinical examination?

"Affirmative. The clinical trial's details hosted on the website, clinicaltrials.gov, reveal that is it currently seeking recruits at this time; with initial posting occurring July 28th 2022 and most recent update being November 8th 2022. 70 individuals need to be enrolled from 7 separate medical centres."

Answered by AI

Has Damoctocog alfa-pegol (Jivi, BAY94-9027) been tested in prior research initiatives?

"As of now, two investigations into Damoctocog alfa-pegol (Jivi, BAY94-9027) are being conducted with one in its third phase. Most trials for this drug take place in Augusta, Georgia though 41 other research sites exist across the USA."

Answered by AI

What medical purpose is Damoctocog alfa-pegol (Jivi, BAY94-9027) typically prescribed for?

"Damoctocog alfa-pegol (Jivi, BAY94-9027) is the most frequently prescribed medication to reduce perioperative blood loss. Similarly, it has been seen as effective in managing hemorrhage and hemophilia among previously treated patients."

Answered by AI

Is this trial currently accepting new participants?

"Per clinicaltrials.gov, this medical research is currently in need of volunteers and has been since July 28th 2022. The trial was most recently updated on November 8th 2022."

Answered by AI

What safety measures have been taken to ensure the efficacy of Damoctocog alfa-pegol (Jivi, BAY94-9027) when utilized by patients?

"Data collected on the safety profile of Damoctocog alfa-pegol (Jivi, BAY94-9027) has been deemed sufficient to classify it as a 3 due its Phase 4 trial status - indicating that this therapy is approved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylaxis Regimen for Hemophilia A Patients

2022. "Prophylaxis Regimen for Hemophilia A Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036278.

All > Hemophilia A > Hemophilia