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

NCT ID: NCT04985318

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-25

Study Completion Date

2034-12-12

Brief Summary

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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.

Detailed Description

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Conditions

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Acquired Thrombotic Thrombocytopenic Purpura

Keywords

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aTTP caplacizumab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Registergroup

Patients with acquired Thrombotic Thrombocytopenic Purpura, who have been treated with caplacizumab (Cablivi®)

Cablivi®

Intervention Type DRUG

Intervention with Cablivi® take place outside of the study

Interventions

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Cablivi®

Intervention with Cablivi® take place outside of the study

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Paul Brinkkoetter

Prof. MD, Consultant in Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linus Völker, MD

Role: PRINCIPAL_INVESTIGATOR

Department II of Internal Medicine, University of Cologne

Locations

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University Hospital of Cologne

Cologne, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Linus Völker, MD

Role: CONTACT

Phone: +49 221 478 86285

Email: [email protected]

Lucas Kühne, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Linus Völker, MD

Role: primary

Lucas Kühne, MD

Role: backup

References

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Volker LA, Kaufeld J, Balduin G, Merkel L, Kuhne L, Eichenauer DA, Osterholt T, Hagele H, Kann M, Grundmann F, Kolbrink B, Schulte K, Gackler A, Kribben A, Boss K, Potthoff SA, Rump LC, Schmidt T, Muhlfeld AS, Schulmann K, Hermann M, Gaedeke J, Sauerland K, Bramstedt J, Hinkel UP, Miesbach W, Bauer F, Westhoff TH, Bruck H, Buxhofer-Ausch V, Muller TJ, Wendt R, Harth A, Schreiber A, Seelow E, Tolle M, Gohlisch C, Bieringer M, Geuther G, Jabs WJ, Fischereder M, von Bergwelt-Baildon A, Schonermarck U, Knoebl P, Menne J, Brinkkoetter PT; German TTP-Study Group. Impact of first-line use of caplacizumab on treatment outcomes in immune thrombotic thrombocytopenic purpura. J Thromb Haemost. 2023 Mar;21(3):559-572. doi: 10.1016/j.jtha.2022.11.010. Epub 2022 Dec 22.

Reference Type DERIVED
PMID: 36696206 (View on PubMed)

Other Identifiers

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V01-19052020

Identifier Type: -

Identifier Source: org_study_id