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NCT Number: NCT04985318

Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP

The objective of this national, prospective, multi-centre observational study is to describe the prescription rational and practice in Germany, confirm the efficacy of caplacizumab in a real-world setting, and identify predicting factors in iTTP-patients with regard to persistent autoimmune activity, therapy guidance and risk of complications. The rational is to develop new treatment algorithms that optimize overall patient outcome and reduce treatment cost.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acquired Thrombotic Thrombocytopenic Purpura Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombotic Thrombocytopenic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombophilia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne

Cologne, 50937, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of an acute episode of acquired thrombotic thrombocytopenic purpura
  • Treatment with at least one single dose of caplacizumab (10 mg i.v. or s.c.)
  • Male or female patients ≥ 18 years of age
  • signed written informed consent

Exclusion criteria

  • Hereditary thrombotic thrombocytopenic purpura
  • disability to give informed consent

Treatment and study plan

Cablivi®

Drug

Intervention with Cablivi® take place outside of the study

Primary outcomes

  1. Treatment of aTTP with caplacizumab

    Time frame: Enrollment

    Description of the prescription rationale and practice of caplacizumab in the treatment of aTTP

Secondary outcomes

  1. Stabilization of thrombocyte

    Time frame: Enrollment

    Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of stabilization of thrombocyte. Thrombocyte stabilization is defined as thrombocyte > 150 x 10E9/L

  2. Normalization of LDH

    Time frame: Enrollment

    Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of normalization of Lactate dehydrogenase (LDH). Normalization of LDH is defined as LDH below upper limit of normal

  3. Normalization of haptoglobin

    Time frame: Enrollment

    Documentation of the efficacy of caplacizumab in the treatment of aTTP outside of clinical trials (real-world data) using by means of normalization of haptoglobin. Normalization of haptoglobin is defined as haptoglobin above lower limit of normal

  4. Risk factors for complications

    Time frame: Enrollment

    Identification of risk factors for complications

  5. Risk factors for adverse outcomes

    Time frame: Enrollment

    Identification of risk factors for adverse outcomes

  6. Risk factors for persistent autoimmune activity

    Time frame: Enrollment

    Identification of risk factors for persistent autoimmune activity

  7. Parameters for therapy guidance

    Time frame: Enrollment

    Identification of parameters that guide duration and regimen of caplacizumab treatment

  8. Effect of caplacizumab on adjunct treatments with PEX

    Time frame: Enrollment

    Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of therapeutic plasma exchange therapy (PEX)

  9. Effect of caplacizumab on adjunct treatments

    Time frame: Enrollment

    Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of glucocorticoids

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020

Acronym: REACT-2020

Important dates

Study start
2021
Primary completion
2034
Study completion
2034
First posted
Aug 2, 2021
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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