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

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).

Study Overview

• Status: Terminated
• Conditions: Thrombotic Thrombocytopenic Purpura
• Intervention / Treatment: Biological: Octaplas; Drug: Standard Plasma

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Octapharma Study Site
    • Rochester, New York, United States, 14642
      • Octapharma Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing Plasma exchange for Thrombotic Thrombocytopenic Purpura

Description

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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: FFP, FP24, 5 day plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Up to 28 days followed by a 24 hour follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Citrate reactions during TPE based on clinical judgment of physician.	Up to 28 days followed by a 24 hour follow-up
Incidence of Plasma-associated adverse reactions including Transfusion-Associated Circulatory Overload (TACO),	Up to 28 days followed by a 24 hour follow-up
Incidence of Transfusion-Related Acute Lung Injury (TRALI)	Up to 28 days followed by a 24 hour follow-up
Incidence of febrile reactions	Up to 28 days followed by a 24 hour follow-up
Measurement of Safety laboratory parameters - International Normalized Ratio (INR)	Up to 28 days followed by a 24 hour follow-up
Measurement of Prothrombin Time (PT)/Partial Thromboplastin Time (PTT).	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).	Up to 28 days followed by a 24 hour follow-up
measurement of Platelet count	Up to 28 days followed by a 24 hour follow-up
measurement of hemoglobin	Up to 28 days followed by a 24 hour follow-up
measurement of hematocrit	Up to 28 days followed by a 24 hour follow-up
measurement of LDH.	Up to 28 days followed by a 24 hour follow-up

Collaborators and Investigators

• Sponsor: Octapharma

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): August 2, 2017
• Study Completion (Actual): August 2, 2017

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 10, 2013

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: TTP; Thrombotic Thrombocytopenic Purpura; Plasma exchange
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Thrombocytopenia; Blood Platelet Disorders; Thrombophilia; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
• Other Study ID Numbers: LAS-214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes