Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
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|ClinicalTrials.gov Identifier: NCT01712438|
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : October 21, 2019
Last Update Posted : January 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Severe Hemophilia A||Biological: Human cl rhFVIII||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 14, 2018|
|Actual Study Completion Date :||December 20, 2019|
|Experimental: Human cl rhFVIII||
Biological: Human cl rhFVIII
- Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors [ Time Frame: maximum 5 years (100 exposure days) ]The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development using the modified Bethesda assay (Nijmegen modification). The definitions for thresholds were ≥0.6 to <5 BU/mL for a "low titre" inhibitor and ≥5 BU/mL for a "high-titre" inhibitor.
- Frequency of Spontaneous Break-through Bleeds [ Time Frame: Maximum 5 years (100 exposure days) ]The annualized bleeding rate (ABR) was calculated during inhibitor-free periods for spontaneous bleeding events (BEs) during prophylactic treatment with Human cl rhFVIII
- Efficacy of Human-cl rhFVIII for the Treatment of Bleeds [ Time Frame: Maximum 5 years (100 exposure days) ]A personal efficacy assessment to assess the efficacy of Human-cl rhFVIII for the on-demand treatment of bleeding episodes. Efficacy was assessed using a four-point scale (excellent, good, moderate, none).
- Efficacy of Human-cl rhFVIII for Surgical Prophylaxis [ Time Frame: Maximum 5 years (100 exposure days) ]An overall efficacy assessment to assess the efficacy of human-cl rhFVIII in surgical prophylaxis of minor and major surgeries. The efficacy assessment was analyzed using a four-point scale (excellent, good, moderate, none).
- The Occurrence of Any Adverse Event (AE) [ Time Frame: 5 years ]The frequency of AEs, as monitored throughout the whole study by the number of patients with at least one adverse event occurrence.
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): NCT01712438
|Study Director:||Sigurd Knaub||Octapharma|