Study identification

EU PAS number

EUPAS1000000548

Study ID

1000000548

Official title and acronym

Real-life data study of the French cohort of patients with Rendu Osler disease treatment with bevacizumab:the CoBevaRO study.

DARWIN EU® study

No

Study countries

France

Study description

This real-world data (RWD) study aims to generate real-world evidence (RWE) on the effectiveness and safety of systemic bevacizumab in the management of bleeding and cardiac manifestations in patients with hereditary hemorrhagic telangiectasia (HHT, also known as Rendu-Osler disease).
The analysis is based on data extracted from the French CIROCO database on October 23, 2024, and focuses on patients with a documented history of bevacizumab treatment between 2009 and 2023.
The study objectives are to characterise real-life prescription practices, including dosing, frequency, and treatment duration;
to assess the safety profile through reported adverse events;
to evaluate clinical effectiveness using parameters such as haemoglobin levels, red blood cell transfusion requirements, iron supplementation, and cardiac index;
to compare the use of originator bevacizumab (AVASTIN®) versus biosimilars;
and to explore differential outcomes across patient subgroups based on age, genetic mutation, and location of arteriovenous malformations.
The ultimate goal is to support optimised therapeutic strategies and inform clinical decision-making in the treatment of HHT-related bleeding.

Study status

Ongoing
Research institutions and networks

Institutions

Hospices Civils de Lyon (HCL)
France
First published:
24/07/2025
Institution Educational Institution Hospital/Clinic/Other health care facility
INSERM
France
First published:
01/02/2024
Institution Other

Networks

OrphanDev

Contact details

Sophie Dupuis-Girod 0000-0002-8834-5526

Primary lead investigator
ORCID number:
0000-0002-8834-5526

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Sources of funding
Non-EU institutional research programme
Pharmaceutical company and other private sector 

More details on funding

This study is funded by both the French National Research Agency (ANR) and Delbert Pharma.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable