Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

NCT05935358 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-12

No results posted yet for this study

Summary

Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

Conditions

  • Severe Hemophilia A

Interventions

DRUG

Nuwiq

Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F).

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Shveta Gupta, MD · Arnold Palmer Hospital for Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2026-08-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Croatia
  • Finland
  • France
  • Germany
  • India
  • Italy
  • North Macedonia
  • Serbia
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935358 on ClinicalTrials.gov