Trials / Completed
CompletedNCT00914459
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
A Non-randomized, Open-label Study To Evaluate The Pharmacokinetics, Safety And Efficacy Of Refacto Af In Previously Treated Pediatric Subjects Less Than Twelve Years Of Age With Severe Hemophilia A (Fviii:c <1%).
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Male
- Age
- 11 Years
- Healthy volunteers
- Not accepted
Summary
The study will be investigating pharmacokinetics, safety and efficacy in patients less than 12 years of age with severe hemophilia A that have been previously treated with Factor VIII products ( including blood products).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Moroctocog alfa ( AF-CC) | Dosing is at the discretion of the Investigator |
| PROCEDURE | Laboratory tests | Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2016-03-01
- Completion
- 2016-04-01
- First posted
- 2009-06-05
- Last updated
- 2017-02-10
- Results posted
- 2016-12-21
Locations
17 sites across 9 countries: Finland, Georgia, Italy, Romania, Serbia, Spain, Sweden, Turkey (Türkiye), Ukraine
Source: ClinicalTrials.gov record NCT00914459. Inclusion in this directory is not an endorsement.