Status:
COMPLETED
A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Lead Sponsor:
Sanofi
Conditions:
Thrombotic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Primary Objective: To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period. Secondary Object...
Detailed Description
Study duration per participant is approximately 2 months up to approximately 6 months in case of treatment extension and recurrence during the study drug treatment period.
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Japanese participant must be 18 years or older at the time of signing the informed consent.
- Participants who have a clinical diagnosis of aTTP (initial or recurrent), which includes thrombocytopenia (defined as platelet count \<100,000/µL), microangiopathic hemolytic anemia as evidenced by red blood cell fragmentation (eg, presence of schistocytes), and increased levels of LDH
- Participants who require initiation of daily PE treatment and have received a maximum of 1 PE treatment prior to enrollment in the study
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Capable of giving signed informed consent
- Exclusion criteria:
- Platelet count ≥100,000/µL,
- Serum creatinine level \> 2.3mg/dL in case platelet count is \> 30,000µL
- Known other causes of thrombocytopenia
- Congenital TTP
- Clinically significant active bleeding or high risk of bleeding
- Malignant arterial hypertension
- Known chronic treatment with anticoagulant treatment that cannot be stopped
- Participants who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
- Participants currently or less than 28 days prior to enrollment in this study, enrolled in a clinical study with another investigational drug or device
- Clinical condition other than that associated with TTP, with life expectancy \< 6 months, such as end-stage malignancy
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04074187
Start Date
October 21 2019
End Date
May 19 2021
Last Update
September 22 2025
Active Locations (12)
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1
Investigational Site Number 3920009
Iruma-Gun, Japan
2
Investigational Site Number 3920014
Kanazawa, Japan
3
Investigational Site Number 3920007
Kashihara-shi, Japan
4
Investigational Site Number 3920013
Kawasaki-Shi, Japan