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 : March 15, 2019
|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'.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695978
|Contact: Sigurd Knaub, PhD||+41 554512141||Sigurd.Knaub@octapharma.ch|
Show 28 Study Locations
|Study Director:||Sigurd Knaub, PhD||Octapharma|