NCT04985318

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Mar 2021Dec 2034

Study Start

First participant enrolled

March 25, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
13.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2034

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

13.7 years

First QC Date

July 21, 2021

Last Update Submit

April 29, 2026

Conditions

Acquired Thrombotic Thrombocytopenic Purpura

Keywords

aTTPcaplacizumab

Outcome Measures

Primary Outcomes (1)

  • Treatment of aTTP with caplacizumab

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

    Enrollment

Secondary Outcomes (9)

  • Stabilization of thrombocyte

    Enrollment

  • Normalization of LDH

    Enrollment

  • Normalization of haptoglobin

    Enrollment

  • Risk factors for complications

    Enrollment

  • Risk factors for adverse outcomes

    Enrollment

  • +4 more secondary outcomes

Study Arms (1)

Registergroup

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

Drug: Cablivi®

Interventions

Cablivi®DRUG

Intervention with Cablivi® take place outside of the study

Registergroup

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male or female subjects with confirmed diagnosis of an acute episode of aquired thrombotic thrombocytopenic purpura, who have been treated with one dose of caplacizumab.

You may qualify if:

  • 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

You may not qualify if:

  • Hereditary thrombotic thrombocytopenic purpura
  • disability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

Location

Related Publications (1)

  • 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.

    PMID: 36696206DERIVED

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Interventions

caplacizumab

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaThrombophiliaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Linus Völker, MD

    Department II of Internal Medicine, University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. MD, Consultant in Nephrology

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 2, 2021

Study Start

March 25, 2021

Primary Completion (Estimated)

December 12, 2034

Study Completion (Estimated)

December 12, 2034

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

DE(1)