Octaplas Adult TTP Trial

NCT01938404 | Terminated DMC FDA Drug

• 1 other identifier: LAS-214
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 2

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

Keywords

Plasma exchange; Thrombotic Thrombocytopenic Purpura; TTP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (2)

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

Drug: Standard Plasma

Interventions

Octaplas BIOLOGICAL

Octoplas infusion solution for IV administration

Octaplas

Standard Plasma DRUG

Plasma given as replacement fluid

Also known as: FFP, FP24, 5 day plasma

standard plasma products

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing Plasma exchange for Thrombotic Thrombocytopenic Purpura

You may qualify if:

• Patient is a male or female at least 18 years of age or older.
• Patient has a diagnosis of TTP or suspicion of TTP that is planned on being treated with TPE within 3 days of study entry.
• Patient has thrombocytopenia (platelets \< 100 x 10P9P/L).
• 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.

You may not qualify if:

• Patient has a history of severe hypersensitivity reaction to plasma-derived products or to FFP.
• Patient has an already known IgA deficiency with documented antibodies against IgA.
• Patient has severe deficiencies of Protein S.
• Patient received more than 1 treatment of plasma exchange or plasma infusion for current episode of TTP prior to randomization.
• 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.

Sponsors & Collaborators

• Octapharma: lead

Study Sites (2)

Octapharma Study Site

Manhasset, New York, 11030, United States

Location

Octapharma Study Site

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Thrombophilia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Wolfgang Frenzel

  International Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 10, 2013
• Study Start: June 6, 2017
• Primary Completion: August 2, 2017
• Study Completion: August 2, 2017
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)