Thrombotic Thrombocytopenic PurpuraNCT03369314
Observational Study of the Use of octaplasLG®.
An observational study of Thrombotic Thrombocytopenic Purpura, run by Octapharma at 14 sites in France.
Trial summary
This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombotic Thrombocytopenic Purpura
- What is being tested?
- octaplasLG®
- Type of treatment
- Injection or infusion
- How many people
- 263 participants
- Where
- 14 sitesFrance
- Study dates
- 2 Mar 2018to 14 Jan 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Analyses will be carried out on all patients included, i.e. who have received at least one unit of octaplasLG®. This population will be stratified based on the different product indications. For the population defined as that of patients with TTP, only those patients for whom the investigator has indicated a confirmed diagnosis of idiopathic TTP will be included in the efficacy analysis (see secondary objective).
Who may be able to join
- The patient is treated with octaplasLG® (receiving at least 1 unit of 200 ml octaplasLG®)
- In accordance with Reference Methodology MR-003, the patient of legal age must be individually informed through an information sheet, and must not oppose participating in this non-interventional study (with no collection of consent). If the patient is unable to receive the information and express any opposition, family members or the trusted person receive the information and must not oppose the collection of data*. For minor patients, one of the holders of parental authority receive the information and must not oppose the collection of data.
- However, the patient in question will be informed if his/her condition later allows.
Who cannot join
- 1) Patient's refusal to participate
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
CH Henri Duffaut
Avignon, 84902
Hôpital de La Cavale Blanche
Brest, 29019
Hôpital Louis Pradel
Bron, 69500
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69641
Hospices Civils de Lyon Hôpital Edouard Herriot
Lyon, 67347
Hôpital de la Conception
Marseille, 13385
APHP Hopital Pitié salpêtrière
Paris, 75651
APHP Hopital Cochin
Paris
CHU Hôpitaux de Rouen
Rouen, 76031
CHRU Hôpital Nord
Saint-Etienne, 42055
Hôpital Foch
Suresnes, 92150
Clinique Pasteur
Toulouse, 31076
CHRU Bretonneau
Tours, 37000
CHU de Nancy
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Observational, Real-life Study of the Use of octaplasLG®.
This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.
Read the detailed description
Prospective, non-interventional, multicentre study meeting a post-marketing need. The data will be collected in all patients who have received at least one infusion of octaplasLG®.
The duration of follow-up is limited to the duration of treatment with octaplasLG® plus 24 h of monitoring after cessation of treatment.
Characteristics of the use of octaplasLG® (indication for the transfusion, degree of urgency, characteristics of plasma infusions, patient characteristics, number of iso-group and/or compatible units administered, tolerance criteria (adverse effects), and efficacy criteria (for patients with confirmed diagnosis of TTP--time to normalization of platelet count) will be collected.
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Being tested
- octaplasLG®
- 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.
octaplasLG®Drug
Data will be collected in all patients who have received at least one infusion of octaplasLG®
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving octaplasLG® | The data will be collected in all patients who have received at least one infusion of octaplasLG® Receives: Drug: octaplasLG® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indication for the transfusion of octaplasLG®
Indication for the transfusion of octaplasLG®
Measured: From start of treatment to 24 hours following treatment with octaplasLG®
Degree of urgency - Ordering department of octaplasLG®
Degree of urgency - Ordering department of octaplasLG®
Measured: From start of treatment to 24 hours following treatment with octaplasLG®
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
Measured: From start of treatment to 24 hours following treatment with octaplasLG®
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
Measured: From start of treatment to 24 hours following treatment with octaplasLG®
Number of iso-group and/or compatible units administered for octaplasLG®
Number of iso-group and/or compatible units administered for octaplasLG®
Measured: From start of treatment to 24 hours following treatment with octaplasLG®
Secondary outcomes (2)
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma including allergic immunological type (e.g. TRALI) and other events (infections, related to the PE procedure (e.g. case of transfusion-associated circulatory overload [TACO], citrate reaction, etc.).
Measured: From start of treatment to 24 hours following treatment with octaplasLG®
Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count > 150 x 109/L on at least 2 consecutive days)
Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count > 150 x 109/L on at least 2 consecutive days)
Measured: From start of treatment to 24 hours following treatment with octaplasLG®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start2 Mar 2018
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
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.
- More trials run by OctapharmaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369314
- Sponsor's protocol ID
- TMA POOL
- Status last verified
- Mar 2021
- First submitted
- 30 Nov 2017
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Real-life Study of the Use of octaplasLG®.
- ClinicalTrials.gov ID
- NCT03369314
- Acronym / sponsor ID
- TMA POOL
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 12 Dec 2017 (actual)
- 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.
This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.
Detailed description
Prospective, non-interventional, multicentre study meeting a post-marketing need. The data will be collected in all patients who have received at least one infusion of octaplasLG®.
The duration of follow-up is limited to the duration of treatment with octaplasLG® plus 24 h of monitoring after cessation of treatment.
Characteristics of the use of octaplasLG® (indication for the transfusion, degree of urgency, characteristics of plasma infusions, patient characteristics, number of iso-group and/or compatible units administered, tolerance criteria (adverse effects), and efficacy criteria (for patients with confirmed diagnosis of TTP--time to normalization of platelet count) will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving octaplasLG® | – | Drug: octaplasLG®The data will be collected in all patients who have received at least one infusion of octaplasLG® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Analyses will be carried out on all patients included, i.e. who have received at least one unit of octaplasLG®. This population will be stratified based on the different product indications. For the population defined as that of patients with TTP, only those patients for whom the investigator has indicated a confirmed diagnosis of idiopathic TTP will be included in the efficacy analysis (see secondary objective).
Key inclusion criteria (3 listed)
- The patient is treated with octaplasLG® (receiving at least 1 unit of 200 ml octaplasLG®)
- In accordance with Reference Methodology MR-003, the patient of legal age must be individually informed through an information sheet, and must not oppose participating in this non-interventional study (with no collection of consent). If the patient is unable to receive the information and express any opposition, family members or the trusted person receive the information and must not oppose the collection of data*. For minor patients, one of the holders of parental authority receive the information and must not oppose the collection of data.
Key exclusion criteria (1 listed)
- 1) Patient's refusal to participate
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 |
|---|---|---|
| octaplasLG®Data will be collected in all patients who have received at least one infusion of octaplasLG® | Drug | Patients Receiving octaplasLG® |
Primary outcome
Indication for the transfusion of octaplasLG®
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Indication for the transfusion of octaplasLG®
Degree of urgency - Ordering department of octaplasLG®
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Degree of urgency - Ordering department of octaplasLG®
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
Number of iso-group and/or compatible units administered for octaplasLG®
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Number of iso-group and/or compatible units administered for octaplasLG®
2 secondary outcomes
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count > 150 x 109/L on at least 2 consecutive days)
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 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 14 sites in France.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Indication for the transfusion of octaplasLG® (time frame: From start of treatment to 24 hours following treatment with octaplasLG®). The study lists 5 primary outcomes in all. 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 19 Mar 2021.