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Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura

A Phase III Double-blind, Randomized, Parallel Group, Multicenter Placebo-controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura

NCT02553317•Ablynx, a Sanofi company

View on ClinicalTrials.gov

Summary

The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
•2. Clinical diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) (initial or recurrent), which included thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
•3. Required initiation of daily PE treatment and had received 1 PE treatment prior to randomization
•4. Others as defined in the protocol

Exclusion Criteria

•1. Platelet count ≥100×10E9/L.
•2. Serum creatinine level \>200 µmol/L in case platelet count is \> 30×10E9/L
•3. Known other causes of thrombocytopenia
•4. Congenital TTP (known at the time of study entry).
•5. Pregnancy or breast-feeding.
•6. Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
•7. Others as defined in the protocol

Locations (101)

Investigator Site

Birmingham, Alabama, United States

Investigator Site

Los Angeles, California, United States

Investigator Site

Atlanta, Georgia, United States

Investigator Site

Boston, Massachusetts, United States

Investigator Site

St Louis, Missouri, United States

Investigator Site

Rochester, New York, United States

Investigator Site

Rochester, New York, United States

Investigator Site

Valhalla, New York, United States

Investigator Site

Chapel Hill, North Carolina, United States

Investigator Site

Durham, North Carolina, United States

Key Dates

Start Date

November 1, 2015

Primary Completion Date

August 1, 2017

Completion Date

August 1, 2017

Last Updated

April 5, 2023

Enrollment

145

ACTUAL participants

Conditions

Acquired Thrombotic Thrombocytopenic Purpura

Interventions

Caplacizumab

BIOLOGICAL

Placebo

BIOLOGICAL

Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

NCT02878603

Acquired Thrombotic Thrombocytopenic Purpura

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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