Octaplas Adult TTP Trial

Thrombotic Thrombocytopenic Purpura Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01938404
• Other study ID #: LAS-214
• Status: Terminated
• Start date: June 6, 2017
• Est. completion date: August 2, 2017

Study information

• Verified date: October 2019
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2, 2017
• Est. primary completion date: August 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic
• Thrombotic Thrombocytopenic Purpura

Intervention

Biological:
• Octaplas
Octoplas infusion solution for IV administration

Drug:
• Standard Plasma
Plasma given as replacement fluid

Locations

Country	Name	City	State
United States	Octapharma Study Site	Manhasset	New York
United States	Octapharma Study Site	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

United States, 

Outcome

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