Octaplas Adult TTP Trial

NCT ID: NCT01938404

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2017-08-02

Brief 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).

Conditions

Thrombotic Thrombocytopenic Purpura

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Octaplas

Patients receiving Octaplas for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures

Octaplas

Intervention Type: BIOLOGICAL

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

Standard Plasma

Intervention Type: DRUG

Plasma given as replacement fluid

Interventions

Octaplas

Octoplas infusion solution for IV administration

Intervention Type: BIOLOGICAL

Standard Plasma

Plasma given as replacement fluid

Intervention Type: DRUG

Other Intervention Names

FFP, FP24, 5 day plasma

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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Octapharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Frenzel

Role: STUDY_DIRECTOR

International Medical Director

Locations

Octapharma Study Site

Manhasset, New York, United States

Octapharma Study Site

Rochester, New York, United States

Countries

United States

Other Identifiers

LAS-214

Identifier Type: -

Identifier Source: org_study_id