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Monoclonal Antibodies

Nuwiq for Hemophilia A (NuPOWER Trial)

Phase 4

Recruiting

Led By Shveta Gupta, MD

Research Sponsored by Octapharma

Eligibility Criteria Checklist

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

Must have

Male patients at least 12 years of age

Previous treatment with any FVIII product(s) for at least 150 exposure days

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tested the use of recombinant factor VIII to prevent bleeding in patients with severe haemophilia A who were undergoing major surgery while already receiving emicizumab prophylaxis.

Who is the study for?

This trial is for male patients aged 12 or older with severe Hemophilia A (less than 1% normal clotting factor VIII activity) who have been treated with any Factor VIII products for at least 150 days and are on regular emicizumab prophylaxis for a minimum of three months before planned major surgery. Consent must be given as per local rules.

What is being tested?

The study tests Nuwiq, a recombinant factor VIII product, to prevent bleeding in patients with severe hemophilia A during major surgeries while they're also receiving emicizumab prophylaxis.

What are the potential side effects?

Potential side effects of Nuwiq may include allergic reactions, development of inhibitors (antibodies against the treatment that can reduce its effectiveness), headache, nausea, and pain at the injection site.

Eligibility Criteria

Inclusion Criteria

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

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I am a male and at least 12 years old.

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I have been treated with Factor VIII products for over 150 days.

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I have been on emicizumab for at least 3 months before a major surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ perioperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~perioperative

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

Blood product transfusion levels

FVIII inhibitor formation

+6 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: 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 / 3Eligibility criteria met