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

September 8, 2023 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
      • Boulogne Billancourt, France
        • Hôpital Ambroise Paré
      • Montpellier, France
        • CHU de Montpellier-Hôpital St Eloi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

  • Patient included in BABH study

Exclusion Criteria:

  • Patients opposition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bevacizumab treatment description after end of BABH study
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_1438

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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