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

  vickiemcdonald@nhs.net

• 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.

  Lay Summary of Study Results:

  Lay summary will be posted to ClinicalTrials.gov
  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: Lay summary will be posted to ClinicalTrials.gov
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: Results have been published for congresses
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Pending
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: No tissue samples were collected for this study
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• 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