Octaplas Adult TTP Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01938404
• Date of registration: 02/09/2013
• Prospective Registration: Yes
• Primary sponsor: Octapharma
• Public title: Octaplas Adult TTP Trial
• Scientific 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
• Date of first enrolment: June 6, 2017
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01938404
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Wolfgang Frenzel
• Affiliation: International Medical Director

Key inclusion & exclusion 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understanding that consent may be withdrawn by the subject at any time without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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Thrombotic Thrombocytopenic Purpura

Intervention(s)

Biological: Octaplas

Drug: Standard Plasma

Primary Outcome(s)

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(s)

measurement of hemoglobin [Time Frame: Up to 28 days followed by a 24 hour follow-up]

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]

measurement of hematocrit [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]

Incidence of Transfusion-Related Acute Lung Injury (TRALI) [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]

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]

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]

Measurement of Prothrombin Time (PT)/Partial Thromboplastin Time (PTT). [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]

Incidence of febrile reactions [Time Frame: Up to 28 days followed by a 24 hour follow-up]

Secondary ID(s)

LAS-214

Source(s) of Monetary Support

Please refer to primary and secondary sponsors