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

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

Contact details

Dr Jose Luis Calleja

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Study protocol
Updated protocol
English (1.6 MB - PDF)View document
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)