Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTP (NCT04720261) | Clinical Trial Compass
TerminatedPhase 2
Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTP
Stopped: Recommendations of the independent oversight committee.
France58 participantsStarted 2021-04-26
Plain-language summary
The aim of the study is to evaluate the efficacy of a personalized caplacizumab regimen based on ADAMTS13 activity monitoring in adult acquired thrombotic thrombocytopenic purpura (aTTP): This study is a phase II, prospective, multicenter non-inferiority single-arm study.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* Adult patients ≥ 18 years;
* Clinical diagnosis of aTTP based on standard clinical and laboratory criteria (French Score ≥ 2): i.e., thrombotic microangiopathy syndrome with platelet count ≤ 30 G/L and serum creatinine ≤ 200 μmol/L; severe ADAMTS13 deficiency is not a requirement for inclusion of patients with a French score of 2 \[31\];
* Patient having read and understood the information letter and signed the Informed Consent Form. If the patient is unable to express his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a close relative of the person concerned). In this case, consent to continue the study will subsequently be requested from the patient (article L1122-1-1 of the CSP);
* Patient affiliated with, or beneficiary of a social security (national health insurance) plan;
* For women:
* Women of childbearing potential :
* Effective contraception according to WHO definition (estrogen-progestin or intrauterine device or tubal ligation) since at least 1 month and;
* Negative blood pregnancy test;
* Women surgically sterile (absence of ovaries and/or uterus);
* Postmenopausal women (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
Exclusion Criteria:
* Platelet count \> 100 G/L;
* Patients with a French score \< 2 (a serum creatinine level \> 200 μmol/L +/- associated with a platelet count \> 30 G/L), in order to exc…
What they're measuring
1
To evaluate the feasibility of a personalized caplacizumab regimen in aTTP based on ADAMTS13 activity monitoring assessed by a composite criteria including mortality, refractoriness and/or exacerbation at 30 days post-PE treatment