Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)

June 19, 2017 updated by: Octapharma

A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)

Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific. Transfusing a patient with an incorrect blood group may have fatal consequences. Uniplas is a universally applicable human plasma, which can be administered irrespective of the patient's blood group. This study will test the safety and efficacy of Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.

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.
Interventional

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.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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
    • Virginia
      • Centreville, Virginia, United States, 20120
        • Contact Octapharma for Facility details

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and above.
  • Definite diagnosis of acute thrombotic thrombocytopenic purpura (TTP).
  • Thrombocytopenia.
  • Diagnostic signs of microangiopathic hemolytic anemia.

Exclusion Criteria:

  • Congenital thrombotic microangiopathies.
  • Alternative secondary cause for microangiopathy.
  • Co-morbid illness limiting life expectancy to less than 3 months independent of TTP.
  • Patients known to be HIV positive.
  • Patients known to have lupus.
  • Refusal to accept blood products.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Uniplas
Participants will receive Uniplas intravenously in 4 cycles of 7 to 9 days each for 1 month. The first cycle will consist of 1.5 plasma volume exchanges (= 75 mL/kg) for 3 consecutive days, followed by a minimum of 4 and a maximum of 6 daily single volume plasma exchanges (= 50 mL/kg). Subsequent treatment will depend upon the response of the participant to the first cycle, as assessed by a blinded assessor.
Biological: Uniplas
Uniplas will be provided frozen in sterile plastic bags.
Other Names:
  • Blood group independent, universally applicable, prion-depleted, solvent/detergent treated, human pooled plasma
Active Comparator: Cryosupernatant plasma
Participants will receive cryosupernatant plasma intravenously in 4 cycles of 7 to 9 days each for 1 month. The first cycle will consist of 1.5 plasma volume exchanges (= 75 mL/kg) for 3 consecutive days, followed by a minimum of 4 and a maximum of 6 daily single volume plasma exchanges (= 50 mL/kg). Subsequent treatment will depend upon the response of the participant to the first cycle, as assessed by a blinded assessor.
Biological: Cryosupernatant plasma
Cryosupernatant plasma will be provided frozen in sterile plastic bags.

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
Measure Description
Time Frame
Change from baseline in (log) platelet count 1 month after treatment initiation
Time Frame: Baseline to Month 1
Log platelet count was reported in units, where 1 unit = 10^9/L platelets.
Baseline to Month 1

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
Measure Description
Time Frame
Percentage of participants who died at 1 and 3 months after treatment initiation
Time Frame: Baseline to Month 3
Baseline to Month 3
Percentage of participants with a complete response (CR), a partial response (PR), a non-response (NR), or a transient response (TR) after the first treatment cycle and at 1 month
Time Frame: Baseline to Month 1
A CR was defined as a platelet count > 150 x 10^9/L on 2 consecutive days, and a decrease of lactate dehydrogenase (LDH) to within 1.25 times the upper limit of the normal range, and a resolution of previous neurological symptoms, and no new neurological symptoms. A PR was defined as at least a 2-fold increase in platelet count from baseline which is > 50 x 10^9/L. A NR was defined as a < 2-fold increase in platelet count, or a platelet count < 50 x 10^9/L, or severe red blood cell (RBC) fragmentation, or the development of new neurological symptoms, or no improvement in neurological status as defined by the level of consciousness. A TR was defined as achievement of a complete or partial response which then deteriorated, defined by a 50% decrease in peak platelet count, or neurological deterioration, or a 100% increase in nadir LDH level, or severe RBC fragmentation.
Baseline to Month 1
Total volume of plasma exchange fluid administered during treatment cycles up to 1 month
Time Frame: Baseline to Month 1
Baseline to Month 1
Time to reach maximum platelet count
Time Frame: Baseline to the end of the study (up to 7 months)
Platelet count was reported in units, where 1 unit = 10^9/L platelets.
Baseline to the end of the study (up to 7 months)
Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study
Time Frame: Baseline to the end of the study (up to 7 months)
The percentage of participants with a CR, PR, NR, or TR, as their best clinical response during the study, is reported. A CR was defined as a platelet count > 150 x 10^9/L on 2 consecutive days, and a decrease of lactate dehydrogenase (LDH) to within 1.25 times the upper limit of the normal range, and a resolution of previous neurological symptoms, and no new neurological symptoms. A PR was defined as at least a 2-fold increase in platelet count from baseline which is > 50 x 10^9/L. A NR was defined as a < 2-fold increase in platelet count, or a platelet count < 50 x 10^9/L, or severe red blood cell (RBC) fragmentation, or the development of new neurological symptoms, or no improvement in neurological status as defined by the level of consciousness. A TR was defined as achievement of a complete or partial response which then deteriorated, defined by a 50% decrease in peak platelet count, or neurological deterioration, or a 100% increase in nadir LDH level, or severe RBC fragmentation.
Baseline to the end of the study (up to 7 months)

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Wolfgang Frenzel, M.D., 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

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.
May 1, 2007

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.
February 1, 2008

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.
February 1, 2008

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).
December 13, 2006

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.
December 14, 2006

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.
December 15, 2006

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.
June 21, 2017

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.
June 19, 2017

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.
June 1, 2017

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.
  • UNI-108

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings