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Octaplas Adult TTP Trial

This study is currently recruiting participants.
Verified September 2017 by Octapharma
Sponsor:
ClinicalTrials.gov Identifier:
NCT01938404
First Posted: September 10, 2013
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Octapharma
  Purpose
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).

Condition Intervention
Thrombotic Thrombocytopenic Purpura Biological: Octaplas Drug: Standard Plasma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Octapharma:

Primary Outcome Measures:
  • The incidence of TEEs in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma issued according to institutional standard of care. [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]

Secondary Outcome Measures:
  • Incidence of Citrate reactions during TPE based on clinical judgment of physician. [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • Incidence of Plasma-associated adverse reactions including Transfusion-Associated Circulatory Overload (TACO), [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • Incidence of Transfusion-Related Acute Lung Injury (TRALI) [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • Incidence of febrile reactions [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • Measurement of Safety laboratory parameters - International Normalized Ratio (INR) [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • Measurement of Prothrombin Time (PT)/Partial Thromboplastin Time (PTT). [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • Determination of overall clinical response (rating scale that takes into account platelet count, LDH levels, creatinine and neurological status). [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • measurement of Platelet count [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • measurement of hemoglobin [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • measurement of hematocrit [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]
  • measurement of LDH. [ Time Frame: Up to 28 days followed by a 24 hour follow-up ]

Estimated Enrollment: 200
Actual Study Start Date: June 6, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Octaplas
Patients receiving Octaplas for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures
Biological: Octaplas
Octoplas infusion solution for IV administration
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
Drug: Standard Plasma
Plasma given as replacement fluid
Other Name: FFP, FP24, 5 day plasma

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing Plasma exchange for Thrombotic Thrombocytopenic Purpura
Criteria

Inclusion Criteria:

  1. Patient is a male or female at least 18 years of age or older.
  2. Patient has a diagnosis of TTP or suspicion of TTP that is planned on being treated with TPE within 3 days of study entry.
  3. Patient has thrombocytopenia (platelets < 100 x 10P9P/L).
  4. 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.

Exclusion Criteria:

  1. Patient has a history of severe hypersensitivity reaction to plasma-derived products or to FFP.
  2. Patient has an already known IgA deficiency with documented antibodies against IgA.
  3. Patient is currently participating in an interventional clinical study or has participated during the past 1 month prior to study inclusion.
  4. Patient has severe deficiencies of Protein S.
  5. Patient received more than 1 treatment of plasma exchange or plasma infusion for current episode of TTP prior to randomization.
  6. Patient is currently taking ACE-inhibitors; in case patient is under ACE-inhibitor treatment a wash-out period of at least 24 hours has to elapse prior the first plasma infusion.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938404


Contacts
Contact: Mikaela Grupp 866-337-1868 ctgov@clinicalresearchmgt.com

Locations
United States, New York
Octapharma Study Site Not yet recruiting
Manhasset, New York, United States, 11030
Octapharma Study Site Recruiting
Rochester, New York, United States, 14642
Sponsors and Collaborators
Octapharma
Investigators
Study Director: Wolfgang Frenzel International Medical Director
  More Information

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01938404     History of Changes
Other Study ID Numbers: LAS-214
First Submitted: September 2, 2013
First Posted: September 10, 2013
Last Update Posted: September 22, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Octapharma:
Plasma exchange
Thrombotic Thrombocytopenic Purpura
TTP

Additional relevant MeSH terms:
Blood Platelet Disorders
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Immune System Diseases
Thrombophilia