An observational study in Hereditary Hemorrhagic Telangiectasia (HHT) and Rendu Osler Disease, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Hospices Civils de Lyon · Observational
Among 20 studies in Telangiectasia, Hereditary Hemorrhagic by Hospices Civils de Lyon — 2 open to participants now, 2 under way, none of them phase 3. Telangiectasia, Hereditary Hemorrhagic · Hospices Civils de Lyon.
Among the 20 studies in Telangiectasia, Hereditary Hemorrhagic by Hospices Civils de Lyon, this one is one of 2 that started in 2009, is one of 8 observational ones, and was the 20th registered.
106 studies on the registry are indexed under Telangiectasia, Hereditary Hemorrhagic; 24 are open to participants now.
Browse Telangiectasia, Hereditary Hemorrhagic studies →2 of the 20 studies in Telangiectasia, Hereditary Hemorrhagic by Hospices Civils de Lyon are open now, in 1 country. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Hospices Civils de Lyon · Sites in France
By country, each count listing its studies:
Of the 17 Telangiectasia, Hereditary Hemorrhagic studies recruiting now, 14 (82%) set no upper age limit and 2 (12%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 5 · Phase 3 3
First in 2006; this study’s year is marked. 2 started in 2009.
This study's enrollment of 244 is above the median of 207 across 41 observational studies indexed under Telangiectasia, Hereditary Hemorrhagic.
Median enrollment 49 across the 12 interventional studies, 196 across the 8 observational. Of the 18 that completed or were terminated, 1 (6%) have results posted.
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Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
1 of the studies in Telangiectasia, Hereditary Hemorrhagic by Hospices Civils de Lyon that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04194619Hospices Civils de LyonPregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study | 2027-02 |
Among the 20 studies in Telangiectasia, Hereditary Hemorrhagic by Hospices Civils de Lyon, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Rendu-Osler disease (RO), also known as Hereditary Haemorrhagic Telangiectasia (HHT), is an autosomal dominant genetic disorder. Its pathophysiology is associated with an imbalance in angiogenic balance. The resulting epistaxis and digestive bleeding can be severe, requiring repeated transfusions in 5% of patients. In addition, some patients with HHT may present with liver damage, leading to high-flow heart failure.
Vascular Endothelial Growth Factor (VEGF) plays a role in the pathophysiology of Rendu-Osler disease, leading to the use of a recombinant anti-VEGF monoclonal antibody, bevacizumab. Studies conducted and promoted by HCL have demonstrated the efficacy and safety of bevacizumab in patients with HHT.
In 2014, bevacizumab was granted orphan drug designation for this disease. The 2020 international guidelines for the diagnosis and management of HHT suggest the use of systemic antiangiogenic agents in cases of epistaxis resistant to other treatments. The use of bevacizumab has been widely published in uncontrolled studies, demonstrating its efficacy in reducing epistaxis, improving anaemia, reducing transfusion dependence and improving quality of life.
In France, bevacizumab is currently prescribed outside the scope of its marketing authorization. Treatment indications are validated within the French network of expert centres and the FAVAmulti rare disease network. In other countries, access to this treatment varies widely according to local regulations, and is currently being evaluated in the European VASCERN network.
The aim of this study is to describe the use of bevacizumab in patients treated for HHT in France.
A Total of 317 patients will be included , all of whom were adults aged 18 years or older, diagnosed with hereditary haemorrhagic telangiectasia, and have received systemic bevacizumab exclusively for HHT-related manifestations.
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Exclusion Criteria:
Patients from the CIROCO database: Adults aged 18 years and older, diagnosed with HHT and have received bevacizumab between 2009 and 2025, in France, for severe HHT-related bleeding or severe hepatic involvement, consistent with established recommendations
Other: Real World data study.
Patients from the CIROCO database: Adults aged 18 years and older, diagnosed with HHT and have received bevacizumab between 2009 and 2025, in France, for severe HHT-related bleeding consistent with established recommendations
Other: Real World data study.
Patients from the CIROCO database: Adults aged 18 years and older, diagnosed with HHT and have received bevacizumab between 2009 and 2025, in France, for severe hepatic involvement, consistent with established recommendations
Other: Real World data study.
Patients from the CIROCO database: Adults aged 18 years and older, diagnosed with HHT and have received bevacizumab between 2009 and 2025, in France, for severe HHT-related bleeding and severe hepatic involvement, consistent with established recommendations
Other: Real World data study.
The bevacizumab population is defined as patients who received at least one bevacizumab injection. Descriptive analyses will be performed using demographic, clinical and genetic data
The cumulated number of RBC (Red Blood Cell) units transfused
The number of RBC units transfused (date and number of units)
Time frame: Efficacy outcomes were assessed across three consecutive 6-month periods: Period P1 (baseline), 6 months prior to the first infusion of bevacizumab ; Period P2, first 6 months following the initial induction infusion ; Period P3, the 6 months immediatel
Hemoglobin values (g/L)
Hemoglobin values were collected continually, the average of all available hemoglobin values were calculated for each period, anemia was defined as an hemoglobin mean level less than 120 g/dl regardless of gender
Time frame: Efficacy outcomes were assessed across three consecutive 6-month periods: Period P1 (baseline), 6 months prior to the first infusion of bevacizumab ; Period P2, first 6 months following the initial induction infusion ; Period P3, the 6 months immediatel
The cumulated amount of iron administrated (mg)
The cumulated amount of iron administrated (mg)
Time frame: Efficacy outcomes were assessed across three consecutive 6-month periods: Period P1 (baseline), 6 months prior to the first infusion of bevacizumab ; Period P2, first 6 months following the initial induction infusion ; Period P3, the 6 months immediatel
The HSS (Hematologic Support Score) was calculated for each period
(Additional information about the outcome measure, if needed for clarification. Limit: 600 characters) HSS is a validated composite metric integrating transfusion burden and iron therapy; HSS =(Units of RBC transfused) + (mg elemental Fe/250)
Time frame: Efficacy outcomes were assessed across three consecutive 6-month periods: Period P1 (baseline), 6 months prior to the first infusion of bevacizumab ; Period P2, first 6 months following the initial induction infusion ; Period P3, the 6 months immediatel
In patients in group 2 (see section 'groups and interventions'), Cardiac index was measured by echocardiography
(Additional information about the outcome measure, if needed for clarification. Limit: 600 characters) A cardiac index of 2.5-3.9L/min/m² was considered normal , irrespective of gender
Time frame: Baseline and 24 weeks afer Day 1 (the first bevacizumab infusion)
To assess the safety profile
A predefined list of common adverse events was available in the database with the option to add newly observed adverse events. Any adverse event is discussed to assess its imputability to bevacizumab and to determine the appropriate management strategy (treatment discontinuation, continuation, or dose adjustment). Survival status was collected systematically.
Time frame: From Day 1 (the first bevacizumab infusion) through treatment completion
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2009 to primary completion in Dec 2024, 191 months.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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