- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06039124
Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH (BEST)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Angers, France, 49933
- Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
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Boulogne Billancourt, France
- Hopital Ambroise Pare
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Montpellier, France
- CHU de Montpellier-Hôpital St Eloi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient included in BABH study
Exclusion Criteria:
- Patients opposition
Study Plan
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.
|
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
Sponsor
Investigators
- Principal Investigator: Sophie DUPUIS-GIROD, PhD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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