Recruiting

Nuwiq

Sponsor:

Octapharma

Code:

NCT05935358

Conditions

Severe Hemophilia A

Eligibility Criteria

Sex: Male

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Nuwiq

Study Details

Brief 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

Study ID

NCT05935358

Start date

Nov 28, 2023

Status verified date

May, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nuwiq

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.

Interventions

Nuwiq

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

Primary outcome measure

  • Overall haemostatic efficacy [ Time Frame: During surgery and until completion of wound healing (e.g. removal of sutures, cessation of drainage, etc.) as defined by the investigator, during the study duration of 30 ± 3 days after the day of surgical procedure ]

Central Contacts and Locations

Central contacts

Sigurd Knaub, PhD

+41 554512141Sigurd.Knaub@octapharma.com

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

Octapharma

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Octapharma on 2026-05-12.