BEST: Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT06039124
• Collaborator: (none)
• Enrollment: 23
• Locations: 3
• Actual Duration (Months): 11
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhagic Hereditary Telangiectasia; HHT	Other: bevacizumab treatment

Study Design

• Study Type: Observational
• Actual Enrollment: 23 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Subsequent Bevacizumab Treatment in Patients With HHT After the End of BABH Interventional Study. A Descriptive Study.
• Actual Study Start Date: Sep 1, 2021
• Actual Primary Completion Date: Jan 1, 2022
• Actual Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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; Descriptive study of HHT patients (bevacizumab treatment, number of RBC transfused)

Outcome Measures

Primary Outcome Measures

1. Bevacizumab treatment description after end of BABH study [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient included in BABH study

Exclusion Criteria:

• Patients opposition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers	Angers		France	49933
2	Hôpital Ambroise Paré	Boulogne Billancourt		France
3	CHU de Montpellier-Hôpital St Eloi	Montpellier		France

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Sophie DUPUIS-GIROD, PhD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT06039124
• Other Study ID Numbers: 69HCL21_1438
• First Posted: Sep 15, 2023
• Last Update Posted: Sep 15, 2023
• Last Verified: Sep 1, 2023

• Keywords provided by Hospices Civils de Lyon: HHT; VEGF therapy; BEVACIZUMAB
• Additional relevant MeSH terms: Telangiectasis; Bevacizumab

Study Results

No Results Posted as of Sep 15, 2023