Postauthorisation Safety Study (PASS) of Avatrombopag in Patients With Severe Chronic Liver Disease (CLD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000310
• EU PAS number:
  EUPAS1000000310
• Study ID:
  1000000310
• Official title and acronym:
  Postauthorisation Safety Study (PASS) of Avatrombopag in Patients With Severe Chronic Liver Disease (CLD)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  Netherlands

  Spain
• Study description:
  This is a non-interventional, multinational descriptive cohort study conducted through secondary data collected via review of existing medical charts from patients managed in routine clinical practice at clinical sites in countries in Europe.; The study will collect patients’ data from adult patients treated with avatrombopag or lusutrombopag or patients receiving platelet transfusions in preparation for an elective invasive procedure. The study will be conducted at approx. 10 to 15 clinical sites in selected European countries managing patients with severe CLD and severe thrombocytopenia.; The study size estimate is based on the number of patients treated with avatrombopag, and the actual study size will be determined mainly by the overall utilisation of avatrombopag in patients with severe CLD before elective invasive procedures at the selected sites in the selected countries. At each site, all eligible patients with severe CLD treated with lusutrombopag or receiving a platelet transfusion before elective invasive procedures will be also included. Based on the study feasibility assessment, most participating sites estimated that 1 to 5 potential patients of Child-Pugh class C or MELD score >24 will receive/have received avatrombopag during the study period due to the rarity of these patients undergoing elective procedures. Based on initial feasibility estimates, it is anticipated that approximately 30 patients with severe CLD receiving avatrombopag could be included in the study. A larger number of patients who received platelet transfusions have data available at the selected sites, and very few patients are expected to have received lusutrombopag as the label includes a warning for its use in patients in Child-Pugh class C. Differences in liver function test values before and after the procedure within (not between) patients exposed to avatrombopag or lusutrombopag or receiving a platelet transfusion will be estimated.
• Study status:
  Planned

Research institutions and networks

Institutions

Erasmus Medical Centre Rotterdam

Klinikum Klagenfurt Vienna in Austria, Hvidovre Hospital Copenhagen in Denmark; Hospital Universitario Puerta de Hierro, Madrid; Hospital Universitario de la Plana, Villareal, Castellón, Hospital Universitario Miguel Servet, Zaragoza

Hospital Universitario Insular de Gran Canaria, Las Palmas

Study timelines

Date when funding contract was signed

Planned: 12/06/2024

Actual: 12/06/2024

Study start date

Planned: 31/12/2024

Data analysis start date

Planned: 29/01/2027

Date of final study report

Planned: 31/03/2027

Sources of funding

Pharmaceutical company and other private sector 

Study protocol

Updated protocol

0305735_Sobi_Doptelet CLD PASS protocol V2.0_FINAL 14Dec2023 - signed.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)