An observational study in Thrombotic Thrombocytopenic Purpura, sponsored by Octapharma. Completed at 14 sites in France. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Octapharma · Observational
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Among 14 studies in Purpura, Thrombotic Thrombocytopenic with a site in France — 2 open to participants now, 3 under way, 1 of them phase 3. Purpura, Thrombotic Thrombocytopenic · France.
Among the 14 studies in Purpura, Thrombotic Thrombocytopenic with a site in France, this one is one of 2 that started in 2018, is one of 4 observational ones, and was the 9th registered.
67 studies on the registry are indexed under Purpura, Thrombotic Thrombocytopenic; 18 are open to participants now.
Browse Purpura, Thrombotic Thrombocytopenic studies →2 of the 14 studies in Purpura, Thrombotic Thrombocytopenic with a site in France are open now. Recruiting first, the newest first:
Assistance Publique - Hôpitaux de Paris · Sites in France
University Hospital, Rouen · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 16 Purpura, Thrombotic Thrombocytopenic studies recruiting now, 12 (75%) set no upper age limit and 1 (6%) stops at 75 or younger; 9 take children under 18; 1 takes healthy volunteers.
This study: all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 263 is above the median of 156 across 27 observational studies indexed under Purpura, Thrombotic Thrombocytopenic.
Median enrollment 75 across the 10 interventional studies, 208 across the 4 observational. Of the 10 that completed or were terminated, 6 (60%) have results posted.
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8 of 14 have an industry lead sponsor. The 8 most frequent:
Octapharma is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Octapharma has 3 studies filed under Purpura, Thrombotic Thrombocytopenic — fewer than ten, so there is no comparison to draw.
2 of the studies in Purpura, Thrombotic Thrombocytopenic with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04683003Phase 3TakedaA Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura | 2027-03-16 |
| NCT06945861University Hospital, RouenImmunological Aspect of Thrombotic Thrombocytopenic Purpura (TTP) | 2027-05-10 |
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Among the 14 studies in Purpura, Thrombotic Thrombocytopenic with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
The data will be collected in all patients who have received at least one infusion of octaplasLG®
Drug: octaplasLG®
Data will be collected in all patients who have received at least one infusion of octaplasLG®
Indication for the transfusion of octaplasLG®
Indication for the transfusion of octaplasLG®
Time frame: 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®
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)
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®
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)
Time frame: 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®
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
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.).
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)
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®
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Jan 2021, 34 months.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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