Trial record 11 of 165 for:    "thrombotic thrombocytopenic purpura" OR "Purpura, Thrombocytopenic"

Octaplas Adult TTP Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01938404
First received: September 2, 2013
Last updated: April 29, 2014
Last verified: April 2014
  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

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 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: 120
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 has a history of TTP relapse.
  6. Patient received more than 1 treatment of plasma exchange or plasma infusion for current episode of TTP prior to randomization.
  7. Patient received treatment for TTP within previous 6 months.
  8. Patient is currently taking ACE-inhibitors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938404

Contacts
Contact: Michael Eppolito, MBA michael.eppolito@octapharma.com

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Octapharma
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01938404     History of Changes
Other Study ID Numbers: LAS-214
Study First Received: September 2, 2013
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Octapharma:
Plasma exchange
Thrombotic Thrombocytopenic Purpura
TTP

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

ClinicalTrials.gov processed this record on July 29, 2014