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

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ClinicalTrials.gov Identifier: NCT06039124
Recruitment Status : Completed
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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
Hemorrhagic Hereditary Telangiectasia HHT Other: bevacizumab treatment

Study Design
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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 : September 1, 2021
Actual Primary Completion Date : January 1, 2022
Actual Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

Inclusion Criteria:

  • Patient included in BABH study

Exclusion Criteria:

  • Patients opposition
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039124


Locations
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France
Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
Angers, France, 49933
Hôpital Ambroise Paré
Boulogne Billancourt, France
CHU de Montpellier-Hôpital St Eloi
Montpellier, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sophie DUPUIS-GIROD, PhD Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT06039124    
Other Study ID Numbers: 69HCL21_1438
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023
Keywords provided by Hospices Civils de Lyon:
HHT
VEGF therapy
BEVACIZUMAB
Additional relevant MeSH terms:
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Telangiectasis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors