BevacizimabPhase 2NCT07828015
Bevacizumab in the Treatment of HHT
A Phase 2 study testing Bevacizumab, nasal electrocoagulation. and Thalidomide (50mg) in people with Bevacizimab and HHT, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Clinical Study Abstract (Ethics Application) Hereditary hemorrhagic telangiectasia (HHT) is a rare autosomal dominant vascular disorder characterized by recurrent intractable epistaxis and multi-organ arteriovenous malformations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bevacizimab, HHT
- What is being tested?
- Bevacizumab, nasal electrocoagulation. and Thalidomide (50mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Definite HHT diagnosis is established by either clinical assessment according to the Curaçao criteria or genetic confirmation.
- Clinical diagnosis (Curaçao criteria)
- Patients who meet at least 3 of the following 4 items are diagnosed with definite HHT:
- Spontaneous, recurrent epistaxis Multiple mucocutaneous telangiectasias at typical sites Visceral arteriovenous malformations (lung, liver, brain, gastrointestinal tract, etc.) Positive family history of HHT in a first-degree relative Genetic diagnosis Identification of a pathogenic germline mutation in HHT-associated genes (ENG, ACVRL1) confirms the diagnosis of HHT.
Who cannot join
- Minors, patients with mild epistaxis that can be well controlled by other treatments, and patients with any contraindication to bevacizumab treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Hong-gang Duan, doctor, 13429124832, 2314061@zju.edu.cn
Hong-gang 段, 2314061@zju.edu.cn
About this study
Official title: Observation on the Efficacy of Bevacizumab in the Treatment of Hereditary Haemorrhagic Telangiectasia
Clinical Study Abstract (Ethics Application) Hereditary hemorrhagic telangiectasia (HHT) is a rare autosomal dominant vascular disorder characterized by recurrent intractable epistaxis and multi-organ arteriovenous malformations. Moderate-to-severe patients often develop refractory anemia with severely impaired quality of life. Current stepwise therapeutic strategies have substantial limitations, including frequent adverse reactions of thalidomide, high recurrence rates after electrocoagulation, and severe surgical trauma, resulting in a lack of safe and individualized treatment options. Our preliminary clinical practice has verified the promising efficacy and long-term benefits of bevacizumab in severe HHT-related epistaxis. However, obvious interindividual variability and occasional adverse events exist, and the underlying mechanism remains unclear. This study aims to systematically evaluate the efficacy and safety of bevacizumab for severe HHT-associated epistaxis, explore the influences of baseline clinical and genetic factors on prognosis, and investigate the mechanism of treatment heterogeneity, so as to optimize individualized therapeutic strategies and provide clinical evidence for precise management of HHT in China.
- Conditions
- Bevacizimab, HHT
- Being tested
- Bevacizumab, nasal electrocoagulation., Thalidomide (50mg)
- Keywords
- HHT, bevacizimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab is administered intravenously at 5 mg/kg body weight, 1 to 2 times annually, starting one month after nasal electrocoagulation.
nasal electrocoagulation.Procedure or surgery
nasal electrocoagulation.
Thalidomide (50mg)Drug
Oral thalidomide is initiated at 50 mg twice daily (100 mg per day) one month after nasal electrocoagulation.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | surgery combined with intravenous injection of bevacizumab Receives: Drug: Bevacizumab; Procedure: nasal electrocoagulation. |
| Active comparator | Active comparator | Surgery combined with oral thalidomide Receives: Procedure: nasal electrocoagulation.; Drug: Thalidomide (50mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESS
Epistaxis Severity Score
Measured: 1,3.6.12 months after surgery
Hb
Hemoglobin (Hb)
Measured: 1,3,6,12months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 May 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BevacizimabStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828015
- Sponsor's protocol ID
- 2025-0369
- Status last verified
- Aug 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on the Efficacy of Bevacizumab in the Treatment of Hereditary Haemorrhagic Telangiectasia
- ClinicalTrials.gov ID
- NCT07828015
- Acronym / sponsor ID
- 2025-0369
- Conditions
- Bevacizimab, HHT
- Keywords
- HHT, bevacizimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 18 Sep 2026 (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.
Clinical Study Abstract (Ethics Application) Hereditary hemorrhagic telangiectasia (HHT) is a rare autosomal dominant vascular disorder characterized by recurrent intractable epistaxis and multi-organ arteriovenous malformations. Moderate-to-severe patients often develop refractory anemia with severely impaired quality of life. Current stepwise therapeutic strategies have substantial limitations, including frequent adverse reactions of thalidomide, high recurrence rates after electrocoagulation, and severe surgical trauma, resulting in a lack of safe and individualized treatment options. Our preliminary clinical practice has verified the promising efficacy and long-term benefits of bevacizumab in severe HHT-related epistaxis. However, obvious interindividual variability and occasional adverse events exist, and the underlying mechanism remains unclear. This study aims to systematically evaluate the efficacy and safety of bevacizumab for severe HHT-associated epistaxis, explore the influences of baseline clinical and genetic factors on prognosis, and investigate the mechanism of treatment heterogeneity, so as to optimize individualized therapeutic strategies and provide clinical evidence for precise management of HHT in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Drug: Bevacizumab, Procedure: nasal electrocoagulation.surgery combined with intravenous injection of bevacizumab |
| Active comparator | Active comparator | Procedure: nasal electrocoagulation., Drug: Thalidomide (50mg)Surgery combined with oral thalidomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Definite HHT diagnosis is established by either clinical assessment according to the Curaçao criteria or genetic confirmation.
- Clinical diagnosis (Curaçao criteria)
- Spontaneous, recurrent epistaxis Multiple mucocutaneous telangiectasias at typical sites Visceral arteriovenous malformations (lung, liver, brain, gastrointestinal tract, etc.) Positive family history of HHT in a first-degree relative Genetic diagnosis Identification of a pathogenic germline mutation in HHT-associated genes (ENG, ACVRL1) confirms the diagnosis of HHT.
Key exclusion criteria (1 listed)
- Minors, patients with mild epistaxis that can be well controlled by other treatments, and patients with any contraindication to bevacizumab treatment.
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 |
|---|---|---|
| BevacizumabBevacizumab is administered intravenously at 5 mg/kg body weight, 1 to 2 times annually, starting one month after nasal electrocoagulation. | Drug | Experiment |
| nasal electrocoagulation.nasal electrocoagulation. | Procedure or surgery | Active comparator, Experiment |
| Thalidomide (50mg)Oral thalidomide is initiated at 50 mg twice daily (100 mg per day) one month after nasal electrocoagulation. | Drug | Active comparator |
Primary outcome
ESS
Time frame: 1,3.6.12 months after surgery
Epistaxis Severity Score
Hb
Time frame: 1,3,6,12months after surgery
Hemoglobin (Hb)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Bevacizimab
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
RecruitingPhase 2
Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Neoadjuvant Therapy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, nasal electrocoagulation. and Thalidomide (50mg) in people with Bevacizimab and HHT, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 4 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong-gang Duan, doctor (13429124832, 2314061@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESS (time frame: 1,3.6.12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.