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Clotting Factor Replacement

Prophylactic FVIII Therapy for Hemophilia A (PREDICT Trial)

Phase 4

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

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

Must not have

Any other inherited or acquired bleeding disorder in addition to hemophilia A. Note: von Willebrand disease should be diagnosed per local clinical practice. Participants with a diagnosis of von Willebrand disease in medical records or diagnosed at the time of screening will be excluded.

The participant has a planned major surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any bleeding disorders besides hemophilia A.

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I have a major surgery planned.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of favorable outcome on the score selected dosing regimen

Secondary study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Damoctocog alfa-pegol is a recombinant B-domain deleted human coagulation FVIII variant site specifically conjugated with a 60 kDa, branched (30 kDa each) polyethylene glycol (PEG).

2022

Completed Phase 4

~30

0 / 4Eligibility criteria met