Trials / Completed
CompletedNCT02256917
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Human cl rhFVIII |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2018-09-01
- Completion
- 2018-09-01
- First posted
- 2014-10-06
- Last updated
- 2021-01-19
- Results posted
- 2019-12-03
Locations
30 sites across 9 countries: United States, Canada, Croatia, Finland, France, Japan, Netherlands, North Macedonia, Slovenia
Source: ClinicalTrials.gov record NCT02256917. Inclusion in this directory is not an endorsement.