Acquired Thrombotic Thrombocytopenic PurpuraREACT-2020NCT04985318
Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP
An observational study of Acquired Thrombotic Thrombocytopenic Purpura, run by University of Cologne at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Thrombotic Thrombocytopenic Purpura
- What is being tested?
- Cablivi®
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2021to 12 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Hereditary thrombotic thrombocytopenic purpura
- disability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020
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.
- Being tested
- Cablivi®
- Keywords
- aTTP, caplacizumab
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cablivi®Drug
Intervention with Cablivi® take place outside of the study
| Study group | Role | What they receive |
|---|---|---|
| Registergroup | Patients with acquired Thrombotic Thrombocytopenic Purpura, who have been treated with caplacizumab (Cablivi®) Receives: Drug: Cablivi® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of aTTP with caplacizumab
Description of the prescription rationale and practice of caplacizumab in the treatment of aTTP
Measured: Enrollment
Secondary outcomes (9)
Stabilization of thrombocyte
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
Measured: Enrollment
Normalization of LDH
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
Measured: Enrollment
Normalization of haptoglobin
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
Measured: Enrollment
Risk factors for complications
Identification of risk factors for complications
Measured: Enrollment
Risk factors for adverse outcomes
Identification of risk factors for adverse outcomes
Measured: Enrollment
Risk factors for persistent autoimmune activity
Identification of risk factors for persistent autoimmune activity
Measured: Enrollment
Parameters for therapy guidance
Identification of parameters that guide duration and regimen of caplacizumab treatment
Measured: Enrollment
Effect of caplacizumab on adjunct treatments with PEX
Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of therapeutic plasma exchange therapy (PEX)
Measured: Enrollment
Effect of caplacizumab on adjunct treatments
Descriptions of the effect of caplacizumab on dose, duration and number and severity of adverse events of glucocorticoids
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start25 Mar 2021
- Primary completion12 Dec 2034 (estimated)
- Study completion12 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acquired Thrombotic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Paul Brinkkoetter, University of Cologne
- Investigators
- Linus Völker, MD, Principal investigator, Department II of Internal Medicine, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985318
- Sponsor's protocol ID
- V01-19052020
- Acronym
- REACT-2020
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuhne L, Volker LA, Schonermarck U, Pfrepper C, Tzalavras A, Wendt R, Schwenger V, Schulte-Kemna L, Osterholt T, Boll B, Shimabukuro-Vornhagen A, Eisinger F, Muhlfeld A, Grasshoff L, Nitschke M, Liebregts T, Petros S, von Bergwelt-Baildon A, Kochanek M, Brinkkoetter PT, Eichenauer DA. Characteristics and Management of Patients With Immune Thrombotic Thrombocytopenic Purpura Admitted to the Intensive Care Unit: A Multicenter Retrospective Analysis. Am J Hematol. 2026 Jan;101(1):198-205. doi: 10.1002/ajh.70125. Epub 2025 Oct 29.
PubMed 41159657Volker 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.
PubMed 36696206
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020
- ClinicalTrials.gov ID
- NCT04985318
- Acronym / sponsor ID
- REACT-2020 / V01-19052020
- Keywords
- aTTP, caplacizumab
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 12 Dec 2034 (estimated)
- Study completion
- 12 Dec 2034 (estimated)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registergroup | – | Drug: Cablivi®Patients with acquired Thrombotic Thrombocytopenic Purpura, who have been treated with caplacizumab (Cablivi®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Hereditary thrombotic thrombocytopenic purpura
- disability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cablivi®Intervention with Cablivi® take place outside of the study | Drug | Registergroup |
Primary outcome
Treatment of aTTP with caplacizumab
Time frame: Enrollment
Description of the prescription rationale and practice of caplacizumab in the treatment of aTTP
9 secondary outcomes
Stabilization of thrombocyte
Time frame: Enrollment
Normalization of LDH
Time frame: Enrollment
Normalization of haptoglobin
Time frame: Enrollment
Risk factors for complications
Time frame: Enrollment
Risk factors for adverse outcomes
Time frame: Enrollment
Risk factors for persistent autoimmune activity
Time frame: Enrollment
Parameters for therapy guidance
Time frame: Enrollment
Effect of caplacizumab on adjunct treatments with PEX
Time frame: Enrollment
Effect of caplacizumab on adjunct treatments
Time frame: Enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 41159657Kuhne L, Volker LA, Schonermarck U, Pfrepper C, Tzalavras A, Wendt R, Schwenger V, Schulte-Kemna L, Osterholt T, Boll B, Shimabukuro-Vornhagen A, Eisinger F, Muhlfeld A, Grasshoff L, Nitschke M, Liebregts T, Petros S, von Bergwelt-Baildon A, Kochanek M, Brinkkoetter PT, Eichenauer DA. Characteristics and Management of Patients With Immune Thrombotic Thrombocytopenic Purpura Admitted to the Intensive Care Unit: A Multicenter Retrospective Analysis. Am J Hematol. 2026 Jan;101(1):198-205. doi: 10.1002/ajh.70125. Epub 2025 Oct 29.
- Derived from this study: PubMed 36696206Volker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linus Völker, MD principal investigator
Department II of Internal Medicine, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Thrombotic Thrombocytopenic Purpura, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of aTTP with caplacizumab (time frame: Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985318, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.