Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients (Protect-NOW)
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|ClinicalTrials.gov Identifier: NCT03695978|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : January 22, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW|
|Actual Study Start Date :||February 13, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
All patients receiving Nuwiq (recombinant FVIII)
All patients receiving Octanate (plasma derived FVIII)
All patients receiving Wilate (plasma derived FVIII/von Willebrand factor [VWF])
- Annualised rate of breakthrough bleeds to assess efficacy in prophylactic treatment [ Time Frame: 100 exposure days ]Annualised rate of all bleeding events (BEs), including all spontaneous, traumatic and joint BEs
- Incidence of Adverse Drug Reactions (ADRs) [ Time Frame: 100 exposure days ]Adverse drug reactions (ADRs) including hypersensitivity reactions will be recorded in by patients in treatment diaries, which will be reviewed at each Follow-up Visit.
- Dosage of FVIII concentrates [ Time Frame: 100 exposure days ]For each individual FVIII injection the dose will be recorded.
- Overall assessment of the effectiveness of surgical prophylaxis by the treating physicians [ Time Frame: 100 exposure days ]At the end of the postoperative period, treating physicians will assess the effectiveness of surgical prophylaxis using a scale including the four items: 'excellent,' 'good,' moderate,' and 'none'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695978
|Contact: Sigurd Knaub, PhD||+41 554512141||Sigurd.Knaub@octapharma.ch|
|Study Director:||Sigurd Knaub, PhD||Octapharma|