Octaplas Adult TTP Trial

October 10, 2019 updated by: Octapharma

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Up to 28 days followed by a 24 hour follow-up
Up to 28 days followed by a 24 hour follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
Up to 28 days followed by a 24 hour follow-up
measurement of hemoglobin
Time Frame: Up to 28 days followed by a 24 hour follow-up
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
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
Up to 28 days followed by a 24 hour follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Octapharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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