Trials / Terminated
TerminatedNCT01938404
Octaplas Adult TTP Trial
Post-Marketing Requirement Study to Evaluate the Safety and Efficacy of Octaplas™ in Patients With Thrombotic Thrombocytopenic Purpura With Special Emphasis on Monitoring the Occurrence of Thromboembolic Events
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess and evaluate the safety of octaplas™ in comparison to standard plasma product (e.g., fresh frozen plasma (FFP) and other approved plasma products used within 24 hours of thawing) used in the treatment of TTP, in patients undergoing Therapeutic Plasma Exchange, with a special emphasis on the occurrence of thromboembolic events (TEEs).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Octaplas | Octoplas infusion solution for IV administration |
| DRUG | Standard Plasma | Plasma given as replacement fluid |
Timeline
- Start date
- 2017-06-06
- Primary completion
- 2017-08-02
- Completion
- 2017-08-02
- First posted
- 2013-09-10
- Last updated
- 2019-10-14
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01938404. Inclusion in this directory is not an endorsement.