Trial record 11 of 157 for:
"thrombotic thrombocytopenic purpura" OR "Purpura, Thrombocytopenic"
Octaplas Adult TTP Trial
This study is not yet open for participant recruitment.
Verified September 2013 by Octapharma
Information provided by (Responsible Party):
First received: September 2, 2013
Last updated: September 9, 2013
Last verified: September 2013
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).
Thrombotic Thrombocytopenic Purpura
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- The number of TEEs reported [ Time Frame: Up to 28 days followed by a 24 hour follow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The frequency of TEEs reported [ Time Frame: Up to 28 days followed by a 24 hour follow-up ] [ Designated as safety issue: Yes ]
- Investigator Responses to the efficacy rating scale [ Time Frame: Up to 28 days followed by a 24 hour follow-up ] [ Designated as safety issue: Yes ]
- Number of Serious ADRs reported [ Time Frame: Up to 28 days followed by a 24 hour follow-up ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
Patients receiving Octaplas for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures
standard plasma products
Patients receiving standard plasma products (e.g., FFP, etc) for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult patients undergoing Plasma exchange for Thrombotic Thrombocytopenic Purpura
- Patient is a male or female at least 18 years of age or older.
- Patient has a diagnosis of TTP or suspicion of TTP that is planned on being treated with TPE within 3 days of study entry.
- Patient has thrombocytopenia (platelets < 100 x 10P9P/L).
- Patient is willing to give voluntary written informed consent before any study-related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Patient has a history of severe hypersensitivity reaction to plasma-derived products or to FFP.
- Patient has an already known IgA deficiency with documented antibodies against IgA.
- Patient is currently participating in an interventional clinical study or has participated during the past 1 month prior to study inclusion.
- Patient has severe deficiencies of Protein S.
- Patient has a history of TTP relapse.
- Patient received more than 1 treatment of plasma exchange or plasma infusion for current episode of TTP prior to randomization.
- Patient received treatment for TTP within previous 6 months.
- Patient is currently taking ACE-inhibitors.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01938404
|University of Pennsylvania
|Philadelphia, Pennsylvania, United States |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 2, 2013
||September 9, 2013
||United States: Food and Drug Administration
Keywords provided by Octapharma:
Thrombotic Thrombocytopenic Purpura
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Signs and Symptoms
Blood Platelet Disorders
Immune System Diseases