Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH

NCT06039124 | Completed

• 1 other identifier: 69HCL21_1438
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hemorrhagic Hereditary Telangiectasia; HHT

Keywords

HHT; VEGF therapy; BEVACIZUMAB

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HHT patients previously included in BABH study

Clinical and therapeutic follow-up of HHT patients for one year after the end of a clinical trial using bevacizumab.

Other: bevacizumab treatment

Interventions

bevacizumab treatment OTHER

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

HHT patients previously included in BABH study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in the BABH study (adults, with a confirmed diagnosis of Rendu-Osler disease, presenting with bleeding requiring regular transfusions).

You may qualify if:

• Patient included in BABH study

You may not qualify if:

• Patients opposition

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers

Angers, 49933, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, France

Location

CHU de Montpellier-Hôpital St Eloi

Montpellier, France

Location

Related Publications (1)

• Dupuis-Girod S, Decullier E, Riviere S, Lavigne C, Grobost V, Leguy-Seguin V, Maillard H, Chinet T, Fargeton AE, Guilhem A, Hermann R. BEST study: one-year descriptive follow-up of bevacizumab treatment in hereditary haemorrhagic telangiectasia post-BABH interventional study. Ther Adv Hematol. 2025 Apr 14;16:20406207241300828. doi: 10.1177/20406207241300828. eCollection 2025.

  PMID: 40290758 DERIVED

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sophie DUPUIS-GIROD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: September 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

FR (3)