Trials / Completed
CompletedNCT02170402
China ADVATE PTP Study
Study to Evaluate Efficacy and Safety of ADVATE in the Treatment of Previously Treated Patients With Hemophilia A
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess efficacy, safety and pharmacokinetics of ADVATE in the treatment and prevention of bleeding episodes (BEs)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Octocog alfa (recombinant human coagulation factor VIII) | * Part 1: Pharmacokinetic (PK) analysis - Subset of 24 participants * Part 2: On-demand treatment regimen * Part 3: Prophylaxis treatment regimen |
Timeline
- Start date
- 2014-06-26
- Primary completion
- 2016-05-31
- Completion
- 2016-05-31
- First posted
- 2014-06-23
- Last updated
- 2021-05-03
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02170402. Inclusion in this directory is not an endorsement.