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Thrombotic Thrombocytopenic Purpura (TTP)Phase 3NCT00411801

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

A Phase 3 study testing Uniplas and Cryosupernatant plasma in people with Thrombotic Thrombocytopenic Purpura (TTP), run by Octapharma at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Uniplas and Cryosupernatant plasma
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
May 2007to Feb 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Contact Octapharma for Facility Details

    Centreville, Virginia, 20120

Other trials in United States

About this study

Official title: 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.

Being tested
Uniplas, Cryosupernatant plasma
Keywords
bleeding disorder, universal plasma, plasma, plasma exchange
Medical subject headings
Purpura, Thrombotic Thrombocytopenic, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UniplasBiological

    Also called Blood group independent, universally applicable, prion-depleted, solvent/detergent treated, human pooled plasma

    Uniplas will be provided frozen in sterile plastic bags.

  • Cryosupernatant plasmaBiological

    Cryosupernatant plasma will be provided frozen in sterile plastic bags.

Study groups in NCT00411801
Study groupRoleWhat they receive
UniplasExperimentalParticipants 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.
Receives: Biological: Uniplas
Cryosupernatant plasmaActive comparatorParticipants 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.
Receives: Biological: Cryosupernatant plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in (log) platelet count 1 month after treatment initiation

    Log platelet count was reported in units, where 1 unit = 10^9/L platelets.

    Measured: Baseline to Month 1

Secondary outcomes (5)

  1. Percentage of participants who died at 1 and 3 months after treatment initiation

    Measured: Baseline to Month 3

  2. 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

    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.

    Measured: Baseline to Month 1

  3. Total volume of plasma exchange fluid administered during treatment cycles up to 1 month

    Measured: Baseline to Month 1

  4. Time to reach maximum platelet count

    Platelet count was reported in units, where 1 unit = 10^9/L platelets.

    Measured: Baseline to the end of the study (up to 7 months)

  5. Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study

    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.

    Measured: Baseline to the end of the study (up to 7 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2006 (estimated)
  2. Study startMay 2007
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Why it stopped: Insufficient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00411801
Sponsor's protocol ID
UNI-108
Status last verified
Jun 2017
First submitted
13 Dec 2006
Last updated
21 Jun 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Uniplas and Cryosupernatant plasma in people with Thrombotic Thrombocytopenic Purpura (TTP), run by Octapharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in (log) platelet count 1 month after treatment initiation (time frame: Baseline to Month 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00411801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.

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