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Bored Studies
RecruitingPhase 4

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

Octapharma · NCT05935358

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12+ · Men only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 4
Target enrollment
28
US sites recruiting
1
Study start
November 28, 2023
Record last updated
May 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Nuwiq

Conditions: Severe Hemophilia A

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Severe haemophilia A (FVIII activity [FVIII:C] \<1%) according to medical history
  • Male patients at least 12 years of age
  • Previous treatment with any FVIII product(s) for at least 150 exposure days
  • On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment
  • Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations

Exclusion Criteria

  • Coagulation disorder other than haemophilia A
  • Present or past FVIII inhibitor (≥0.6 Bethesda units [BU]/mL) according to medical history
  • Severe liver or kidney disease (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels >5 times the upper limit of normal; or creatinine >120 μmol/L)
  • Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
  • Already had surgery in this study
  • Current participation in another interventional clinical trial
  • Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

Recruiting US locations

Study contacts (from the official record)

  • Sigurd Knaub, PhD · +41 554512141 · Sigurd.Knaub@octapharma.com
Nuwiq for Perioperative Management Of Patients With Haemophilia A… (NCT05935358) | Bored Studies