Bevacizumab in the Treatment of HHT

NCT07828015 | Recruiting Phase 2

• 1 other identifier: 2025-0369
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

HHT; bevacizimab

Outcome Measures

Primary Outcomes (2)

• ESS

  Epistaxis Severity Score

  1,3.6.12 months after surgery

• Hb

  Hemoglobin (Hb)

  1,3,6,12months after surgery

Study Arms (2)

Experiment

EXPERIMENTAL

surgery combined with intravenous injection of bevacizumab

Drug: Bevacizumab; Procedure: nasal electrocoagulation.

Active comparator

ACTIVE COMPARATOR

Surgery combined with oral thalidomide

Procedure: nasal electrocoagulation.; Drug: Thalidomide (50mg)

Interventions

Bevacizumab DRUG

Bevacizumab is administered intravenously at 5 mg/kg body weight, 1 to 2 times annually, starting one month after nasal electrocoagulation.

Experiment

nasal electrocoagulation. PROCEDURE

nasal electrocoagulation.

Active comparator; Experiment

Thalidomide (50mg) DRUG

Oral thalidomide is initiated at 50 mg twice daily (100 mg per day) one month after nasal electrocoagulation.

Active comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Minors, patients with mild epistaxis that can be well controlled by other treatments, and patients with any contraindication to bevacizumab treatment.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab; Thalidomide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Hong-gang Duan, doctor

CONTACT

13429124832; 2314061@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 18, 2026

Record last verified: 2026-08

Locations

CN (1)