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Factor VIII Replacement

Nuwiq for Hemophilia A

Phase 4

Recruiting

Led By Johannes Oldenburg

Research Sponsored by Octapharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 12 years of age

Scheduled to undergo major elective surgery requiring FVIII treatment

Must not have

Coagulation disorder other than haemophilia A

Already had surgery in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery: from first skin incision to last suture

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to study the use of recombinant factor VIII to prevent bleeding in females with hemophilia A who are undergoing major surgery.

Who is the study for?

This trial is for women and girls aged 12 or older with Hemophilia A, which means they have a Factor VIII level of at least 1% but less than 40%. They must be scheduled for major elective surgery that requires treatment with Factor VIII and agree to participate by signing a consent form.

What is being tested?

The study is testing Nuwiq, a recombinant factor VIII product. It's used to prevent bleeding in female patients with Hemophilia A who are about to undergo major surgery. The focus is on how well Nuwiq works and its safety during surgical procedures.

What are the potential side effects?

While the specific side effects aren't listed here, typical ones associated with factor VIII products include allergic reactions, development of inhibitors (antibodies against the treatment), injection site reactions, headache, fever, nausea, dizziness.

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.

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I am scheduled for a major surgery that will need Factor VIII treatment.

Exclusion Criteria

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

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I have a blood clotting disorder that is not haemophilia A.

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I have already undergone surgery as part of this study.

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I have or had a Factor VIII inhibitor level of 0.6 BU/mL or higher.

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My liver and kidney functions are within normal limits.

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I am allergic to Nuwiq or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ≤30 minutes before and 15-30 minutes after nuwiq injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~≤30 minutes before and 15-30 minutes after nuwiq injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and ≤30 minutes before and 15-30 minutes after nuwiq injection for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall haemostatic efficacy

Secondary study objectives

Adverse events

Allogenic blood products

FVIII inhibitor formation

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

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

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: NuwiqExperimental Treatment1 Intervention

All patients receiving Nuwiq (recombinant FVIII). Nuwiq will be administered intravenously in accordance with the relevant prescribing information. Treatment will be repeated as necessary every 8-24 hours until adequate wound healing, then - if required - for at least another 7 days to maintain FVIII plasma levels of 30-60 IU/dL.

0 / 7Eligibility criteria met