Thrombotic Thrombocytopenic PurpuraNCT01938404
Octaplas Adult TTP Trial
An observational study of Thrombotic Thrombocytopenic Purpura, run by Octapharma at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombotic Thrombocytopenic Purpura
- What is being tested?
- Octaplas and Standard Plasma
- Type of treatment
- Injection or infusion
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2017to 2 Aug 2017
- Phase
- Observational
- 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
Study population: Adult patients undergoing Plasma exchange for Thrombotic Thrombocytopenic Purpura
Who may be able to join
- 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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- 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 is currently participating in an interventional clinical study or has participated during the past 1 month prior to study inclusion.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Octapharma Study Site
Manhasset, New York, 11030
Octapharma Study Site
Rochester, New York, 14642
About this study
Official title: 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).
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Being tested
- Octaplas, Standard Plasma
- Keywords
- Plasma exchange, Thrombotic Thrombocytopenic Purpura, TTP
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctaplasBiological
Octoplas infusion solution for IV administration
Standard PlasmaDrug
Also called FFP, FP24, 5 day plasma
Plasma given as replacement fluid
| Study group | Role | What they receive |
|---|---|---|
| Octaplas | Patients receiving Octaplas for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures Receives: 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 Receives: Drug: Standard Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 28 days followed by a 24 hour follow-up
Incidence of Plasma-associated adverse reactions including Transfusion-Associated Circulatory Overload (TACO),
Measured: Up to 28 days followed by a 24 hour follow-up
Incidence of Transfusion-Related Acute Lung Injury (TRALI)
Measured: Up to 28 days followed by a 24 hour follow-up
Incidence of febrile reactions
Measured: Up to 28 days followed by a 24 hour follow-up
Measurement of Safety laboratory parameters - International Normalized Ratio (INR)
Measured: Up to 28 days followed by a 24 hour follow-up
Measurement of Prothrombin Time (PT)/Partial Thromboplastin Time (PTT).
Measured: 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).
Measured: Up to 28 days followed by a 24 hour follow-up
measurement of Platelet count
Measured: Up to 28 days followed by a 24 hour follow-up
measurement of hemoglobin
Measured: Up to 28 days followed by a 24 hour follow-up
measurement of hematocrit
Measured: Up to 28 days followed by a 24 hour follow-up
measurement of LDH.
Measured: Up to 28 days followed by a 24 hour follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study start6 Jun 2017
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
Why it stopped: FDA released from conducting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Frenzel, Study director, International Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938404
- Sponsor's protocol ID
- LAS-214
- Status last verified
- Oct 2019
- First submitted
- 2 Sep 2013
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01938404
- Acronym / sponsor ID
- LAS-214
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Keywords
- Plasma exchange, Thrombotic Thrombocytopenic Purpura, TTP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: FDA released from conducting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octaplas | – | Biological: OctaplasPatients receiving Octaplas for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures |
| standard plasma products | – | Drug: Standard PlasmaPatients receiving standard plasma products (e.g., FFP, etc) for the treatment of Thrombotic Thrombocytopenic Purpura (TTP) undergoing therapeutic plasma exchange (TPE) procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing Plasma exchange for Thrombotic Thrombocytopenic Purpura
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 is currently participating in an interventional clinical study or has participated during the past 1 month prior to study inclusion.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctaplasOctoplas infusion solution for IV administration | Biological | Octaplas |
| Standard PlasmaAlso: FFP, FP24, 5 day plasmaPlasma given as replacement fluid | Drug | standard plasma products |
Primary outcome
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
11 secondary outcomes
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
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
Incidence of Transfusion-Related Acute Lung Injury (TRALI)
Time frame: 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
Measurement of Safety laboratory parameters - International Normalized Ratio (INR)
Time frame: 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
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
measurement of Platelet count
Time frame: 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
measurement of hematocrit
Time frame: 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
Results and safety
The study was stopped early (reason given: FDA released from conducting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Frenzel study director
International Medical Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombotic Thrombocytopenic Purpura, run by Octapharma at 2 sites 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study was stopped early (reason given: FDA released from conducting). 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2019.