Hemorrhagic Hereditary TelangiectasiaBESTNCT06039124
Subsequent Bevacizumab Treatment in Patients With HHT. Follow up BABH
An observational study of Hemorrhagic Hereditary Telangiectasia and HHT, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhagic Hereditary Telangiectasia, HHT
- What is being tested?
- bevacizumab treatment
- How many people
- 23 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Sep 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in the BABH study (adults, with a confirmed diagnosis of Rendu-Osler disease, presenting with bleeding requiring regular transfusions).
Who may be able to join
- Patient included in BABH study
Who cannot join
- Patients opposition
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Médecine Interne et Maladies Vasculaires + Service Neuropédiatrie et neurochirurgie de l'enfant - CHU Angers
Angers, 49933
Hôpital Ambroise Paré
Boulogne-Billancourt
CHU de Montpellier-Hôpital St Eloi
Montpellier
About this study
Official title: 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.
- Conditions
- Hemorrhagic Hereditary Telangiectasia, HHT
- Being tested
- bevacizumab treatment
- Keywords
- HHT, VEGF therapy, BEVACIZUMAB
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab treatmentOther
Descriptive study of HHT patients (bevacizumab treatment, number of RBC transfused)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: bevacizumab treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bevacizumab treatment description after end of BABH study
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Sep 2021
- Primary completion1 Jan 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic Hereditary TelangiectasiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie DUPUIS-GIROD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039124
- Sponsor's protocol ID
- 69HCL21_1438
- Acronym
- BEST
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Dupuis-Girod S, Decullier E, Riviere S, Lavigne C, Grobost V, Leguy-Seguin V, Maillard H, Chinet T, Fargeton AE, Guilhem A, Hermann R. BEST study: one-year descriptive follow-up of bevacizumab treatment in hereditary haemorrhagic telangiectasia post-BABH interventional study. Ther Adv Hematol. 2025 Apr 14;16:20406207241300828. doi: 10.1177/20406207241300828. eCollection 2025.
PubMed 40290758
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subsequent Bevacizumab Treatment in Patients With HHT After the End of BABH Interventional Study. A Descriptive Study.
- ClinicalTrials.gov ID
- NCT06039124
- Acronym / sponsor ID
- BEST / 69HCL21_1438
- Conditions
- Hemorrhagic Hereditary Telangiectasia, HHT
- Keywords
- HHT, VEGF therapy, BEVACIZUMAB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HHT patients previously included in BABH study | – | Other: bevacizumab treatmentClinical and therapeutic follow-up of HHT patients for one year after the end of a clinical trial using bevacizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the BABH study (adults, with a confirmed diagnosis of Rendu-Osler disease, presenting with bleeding requiring regular transfusions).
Key inclusion criteria (1 listed)
- Patient included in BABH study
Key exclusion criteria (1 listed)
- Patients opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab treatmentDescriptive study of HHT patients (bevacizumab treatment, number of RBC transfused) | Other | HHT patients previously included in BABH study |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 40290758Dupuis-Girod S, Decullier E, Riviere S, Lavigne C, Grobost V, Leguy-Seguin V, Maillard H, Chinet T, Fargeton AE, Guilhem A, Hermann R. BEST study: one-year descriptive follow-up of bevacizumab treatment in hereditary haemorrhagic telangiectasia post-BABH interventional study. Ther Adv Hematol. 2025 Apr 14;16:20406207241300828. doi: 10.1177/20406207241300828. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie DUPUIS-GIROD, PhD principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhagic Hereditary Telangiectasia and HHT, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bevacizumab treatment description after end of BABH study (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06039124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.