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An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP

NCT ID: NCT04943042

Last Updated: 2025-07-14

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

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-22

Study Completion Date

2025-06-10

Brief Summary

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This is a multi-center, observational, Phase 4 study in patients with Immune Thrombocytopenia (ITP) designed to describe the real-world effectiveness of Doptelet and assess the patterns of drug utilization to add to the knowledge base regarding the use of Doptelet in routine medical practice. Patients eligible for participation will, as part of their routine medical care, be receiving Doptelet for the treatment of ITP.

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Detailed Description

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This is a multi-center, observational, Phase 4 study in patients with ITP designed to describe the real-world effectiveness of Doptelet and assess the patterns of drug utilization to add to the knowledge base regarding the use of Doptelet in routine medical practice.

Patients eligible for participation will, as part of their routine medical care, be receiving Doptelet for the treatment of ITP.

The scope of the study is to collect both retrospective and prospective data. The main part of the study will be prospective collecting data on usage, effectiveness, safety, patient- and clinician-reported outcomes and health economic parameters whereas the retrospective part will consist of collection of information on previous treatments, reason for treatment switch, healthcare resource use and, if applicable, Doptelet treatment prior to enrollment. The retrospective data collection will be based on the information available in the patient's medical records. Data will be collected for up to 12 months prior to Doptelet treatment start.

Prospective data will be collected at routine clinical visits throughout the study. Patients will be followed for 12 (+6) months and will be enrolled until their first scheduled visit after 12 months of enrollment, or until early termination, whichever occurs first.

Conditions

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Immune Thrombocytopenia ITP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Full-analysis set (FAS)

The FAS includes all enrolled patients. The FAS will be used for all analyses.

Avatrombopag

Intervention Type DRUG

According to prescription

Interventions

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Avatrombopag

According to prescription

Intervention Type DRUG

Other Intervention Names

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Doptelet®

Eligibility Criteria

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Inclusion Criteria

1. Patient is ≥18 years of age
2. Established and well documented ITP diagnosis
3. Patient is treated with, or at enrollment prescribed, Doptelet for ITP. Decision to initiate treatment shall be made by the treating physician and independently from the decision to include the patient in the study
4. Signed and dated informed consent provided by the patient before any study-related activities are undertaken
5. Willing and able to comply with protocol requirements

Exclusion Criteria

1. Enrollment in a concurrent clinical interventional study, or intake of an Investigational Medicinal Product (IMP), within three months prior to inclusion in this study
2. ITP secondary to Evan's syndrome, lupus and other autoimmune diseases
3. ITP secondary to other hematological disorders and hematological malignancies
4. ITP secondary to any other malignancies
5. ITP secondary to known drug toxicity
6. ITP secondary to any other disease considered relevant by the Investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nina Skuban, MD

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum AB

Vickie McDonald, MD

Role: STUDY_DIRECTOR

Royal London Hospital, London, UK

Locations

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Swedish Orphan Biovitrum Research Site 131

Zagreb, , Croatia

Site Status

Swedish Orphan Biovitrum Research Site 122

Brno, , Czechia

Site Status

Swedish Orphan Biovitrum Research Site 123

Ostrava, , Czechia

Site Status

Swedish Orphan Biovitrum Research Site 121

Prague, , Czechia

Site Status

Swedish Orphan Biovitrum Research Site 124

Prague, , Czechia

Site Status

Swedish Orphan Biovitrum Research Site 125

Prague, , Czechia

Site Status

Swedish Orphan Biovitrum Research Site 108

Aschaffenburg, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 114

Augsburg, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 116

Augsburg, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 103

Bad Homburg, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 106

Berlin, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 113

Dresden, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 102

Frankfurt, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 105

Frankfurt, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 104

Hanover, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 112

Kaiserslautern, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 101

Kassel, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 115

Leipzig, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 109

Schorndorf, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 111

Stolberg, , Germany

Site Status

Swedish Orphan Biovitrum Research Site 509

Bologna, , Italy

Site Status

Swedish Orphan Biovitrum Research Site 504

Catania, , Italy

Site Status

Swedish Orphan Biovitrum Research Site 502

Florence, , Italy

Site Status

Swedish Orphan Biovitrum Research Site 506

Meldola, , Italy

Site Status

Swedish Orphan Biovitrum Research Site 511

Milan, , Italy

Site Status

Swedish Orphan Biovitrum Research Site 510

Milan, , Italy

Site Status

Swedish Orphan Biovitrum Research Site 503

Roma, , Italy

Site Status

Swedish Orphan Biovitrum Research Site 505

Rome, , Italy

Site Status

Swedish Orphan Biovitrum Research Site 202

Apeldoorn, , Netherlands

Site Status

Swedish Orphan Biovitrum Research Site 204

Arnhem, , Netherlands

Site Status

Swedish Orphan Biovitrum Research Site 203

The Hague, , Netherlands

Site Status

Swedish Orphan Biovitrum Research Site 302

Bergen, , Norway

Site Status

Swedish Orphan Biovitrum Research Site 301

Oslo, , Norway

Site Status

Swedish Orphan Biovitrum Research Site 611

Barcelona, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 609

Burgos, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 610

Granada, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 601

Madrid, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 605

Madrid, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 607

Murcia, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 606

Oviedo, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 608

Palma de Mallorca, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 602

Salamanca, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 604

Seville, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 603

Vigo, , Spain

Site Status

Swedish Orphan Biovitrum Research Site 802

Basel, , Switzerland

Site Status

Swedish Orphan Biovitrum Research Site 801

Lausanne, , Switzerland

Site Status

Swedish Orphan Biovitrum Research Site 709

Edinburgh, Scotland, United Kingdom

Site Status

Swedish Orphan Biovitrum Research Site 708

Glasgow, Scotland, United Kingdom

Site Status

Swedish Orphan Biovitrum Research Site 701

Bristol, , United Kingdom

Site Status

Swedish Orphan Biovitrum Research Site 704

Leicester, , United Kingdom

Site Status

Swedish Orphan Biovitrum Research Site 707

London, , United Kingdom

Site Status

Swedish Orphan Biovitrum Research Site 710

London, , United Kingdom

Site Status

Swedish Orphan Biovitrum Research Site 705

Newcastle, , United Kingdom

Site Status

Swedish Orphan Biovitrum Research Site 702

Nottingham, , United Kingdom

Site Status

Swedish Orphan Biovitrum Research Site 703

Oxford, , United Kingdom

Site Status

Countries

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Croatia Czechia Germany Italy Netherlands Norway Spain Switzerland United Kingdom

Other Identifiers

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Sobi.Doptelet-001

Identifier Type: -

Identifier Source: org_study_id

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