Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH (BEST)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06039124 |
Recruitment Status :
Completed
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
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) |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
- Patient included in BABH study
Exclusion Criteria:
- Patients opposition
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
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 |
Principal Investigator: | Sophie DUPUIS-GIROD, PhD | Hospices Civils de Lyon |
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 |
HHT VEGF therapy BEVACIZUMAB |
Telangiectasis Vascular Diseases Cardiovascular Diseases Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |