Recruiting

Nuwiq, Octanate, Wilate

Sponsor:

Octapharma

Code:

NCT03695978

Conditions

Haemophilia A

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

Conditions

Haemophilia A

Study ID

NCT03695978

Start date

Feb 13, 2018

Status verified date

Nov, 2025

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female patients of any age and ethnicity
  • Severe haemophilia A (FVIII:C<1%)
  • Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study
  • Either
  • No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR
  • Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if
  • data are available on all previous treatment, AND
  • they did not develop an inhibitor at any time point, OR
  • they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).
  • Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian)

Exclusion Criteria:

  • Diagnosis with a coagulation disorder other than haemophilia A
  • Concomitant treatment with any systemic immunosuppressive drug
  • Participation in an interventional clinical trial during the time period evaluated
  • Participation in another non-interventional study of Octapharma

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Nuwiq

All patients receiving Nuwiq (recombinant FVIII)

Octanate

All patients receiving Octanate (plasma derived FVIII)

Wilate

All patients receiving Wilate (plasma derived FVIII/von Willebrand factor \[VWF\])

Primary outcome measure

  • Annualised rate of breakthrough bleeds to assess efficacy in prophylactic treatment [ Time Frame: 100 exposure days ]
  • Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: 100 exposure days ]

Central Contacts and Locations

Central contacts

Cristina Solomon, MD

+41 79 585 90 42Cristina.Solomon@octapharma.com

Locations

University of Miami Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

More Information

Sponsor

Octapharma

Last update posted

Jun 2, 2026

Last verified

Nov, 2025

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 2026-06-02.