Actively Recruiting

Phase 4
Age: 12Years +
MALE
NCT05935358

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

Led by Octapharma · Updated on 2026-05-12

28

Participants Needed

18

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 12 years or older
  • Severe haemophilia A with factor VIII activity less than 1% as per medical history
  • Previous treatment with any factor VIII products for at least 150 exposure days
  • On regular emicizumab prophylaxis for at least 1 month before scheduled major elective surgery needing factor VIII treatment
  • Provided freely given written informed consent according to local regulations
Not Eligible

You will not qualify if you...

  • Any coagulation disorder other than haemophilia A
  • Present or past factor VIII inhibitor of 0.6 Bethesda units/mL or higher
  • Severe liver or kidney disease (ALT and/or AST levels more than 5 times upper normal limit, or creatinine over 120 bcmol/L)
  • Known allergy to Nuwiq or its ingredients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
  • Already undergone surgery in this study
  • Current participation in another interventional clinical trial
  • Treatment with any investigational medicinal product within 30 days before screening visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

2

University Hospital Centre Zagreb

Zagreb, Croatia

Actively Recruiting

3

Helsinki University Hospital

Helsinki, Finland

Actively Recruiting

4

CHU de Nantes Hôtel-Dieu

Nantes, France

Actively Recruiting

5

CHRU de Tours

Tours, France

Actively Recruiting

6

Vivantes Klinikum im Friedrichshein (KFH)

Berlin, Germany

Actively Recruiting

7

Gerinnungszentrum Rhein-Ruhr

Duisburg, Germany

Actively Recruiting

8

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany

Actively Recruiting

9

Christian Medical College Vellore

Vellore, Tamil Nadu, India

Actively Recruiting

10

St. John's Medical College Hospital

Bengaluru, India

Actively Recruiting

11

Azienda Ospedaliera Pugliese Ciaccio

Catanzaro, Italy

Actively Recruiting

12

Azienda Ospedaliero Universitaria Careggi - Centro Emofilia

Florence, Italy

Actively Recruiting

13

Centro Trombosi e Malattie Emorragiche, ITCCS Humanitas Research Hospital

Milan, Italy

Actively Recruiting

14

Centre for Haemopilia, Institute for transfusion medicine of Republic of North Macedonia

Skopje, North Macedonia

Actively Recruiting

15

Clinical Center for Serbia Belgrade

Belgrade, Serbia

Actively Recruiting

16

Hospital Universitario La Paz

Madrid, Spain

Actively Recruiting

17

Hospital Universitario Virgen del Rocio

Seville, Spain

Actively Recruiting

18

St. James's University Hospital

Leeds, United Kingdom

Not Yet Recruiting

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Research Team

S

Sigurd Knaub, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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