Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH

HHT Clinical Trial

— BEST  

Official title:

Subsequent Bevacizumab Treatment in Patients With HHT After the End of BABH Interventional Study. A Descriptive Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06039124
• Other study ID #: 69HCL21_1438
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bevacizumab is widely prescribed for the treatment of severe bleeding related to epistaxis or gastrointestinal bleeding in HHT. We studied the efficacy of bevacizumab on severe bleeding in HHT patients in a randomized study recently published (NCT03227263, J Int Med 2023). In this study, 24 patients were included, 12 patients received bevacizumab and 12 patients received placebo. The duration of patient participation was 6 months, including the 2.5-month treatment period and 3.5 month follow-up after treatment. We describe the evolution of the number of RBC transfused in HHT patients who received bevacizumab during the year after the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient included in BABH study

Exclusion Criteria:

• Patients opposition

Related Conditions & MeSH terms

• Hemorrhagic Hereditary Telangiectasia
• HHT
• Telangiectasis

Intervention

Other:
• bevacizumab treatment
Descriptive study of HHT patients (bevacizumab treatment, number of RBC transfused)

Locations

Country	Name	City	State
France	Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers	Angers
France	Hôpital Ambroise Paré	Boulogne Billancourt
France	CHU de Montpellier-Hôpital St Eloi	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bevacizumab treatment description after end of BABH study	Number of patients who received bevacizumab after BABH study. Among patients who received bevacizumab in BABH study: description of re-treatments.; In patients who received placebo in BABH study: description of treatments.	12 months