ADOPT
Research type
Research Study
Full title
An observational, multicenter study to evaluate the use and effectiveness of Doptelet® (Avatrombopag) in adult patients with Immune Thrombocytopenia (ITP)
IRAS ID
323145
Contact name
Vickie McDonald
Contact email
Sponsor organisation
Swedish Orphan Biovitrum AB (publ)
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
The sponsor Swedish Orphan Biovitrum AB (publ) is conducting a health research study to evaluate the use and effectiveness of Doptelet® (Avatrombopag) in adult patients with Immune Thrombocytopenia (ITP).
The purpose of this observational study is to better understand how Doptelet is prescribed and how well it works as treatment for ITP in routine medical practice. This will be done by asking the patient's doctor to record information such as their prescriptions for Doptelet and other ITP medications, their platelet count (which is measured as part of routine care and indicates how well Doptelet works), any doctor’s visit, test or procedure they undergo during the study, and whether any side effects have occurred. Patients will also be asked directly about their experience with Doptelet and their health and symptoms during the study.
The doctor will also ask the patient to complete 7 questionnaires during routine visits about their experience with Doptelet and their health and symptoms during the study. Filling out the questionnaires should take approximately 30 minutes. If preferred, patients can complete questionnaires only at the first visit after enrolment, at approximately 6 months of enrolment and at their last study visit.
The study will not change the frequency of patients' visits to their doctor, or the clinical care that they are currently receiving, and no additional visits will be required.
There will be approximately 150 patients in this study from 35-45 sites in selected European countries. The information collection will continue for as long as the patient and their doctor think it is appropriate or until they have completed the study. Patients will be in this study for a maximum of 18 months.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0083
Date of REC Opinion
5 Apr 2023
REC opinion
Favourable Opinion