Bevacizumab in the Treatment of HHT

ConditionsBevacizimabHHT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Definite HHT diagnosis is established by either clinical assessment according to the Curaçao criteria or genetic confirmation.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bevacizumab

    Drug

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

  • nasal electrocoagulation.

    Procedure/Surgery

    nasal electrocoagulation.

  • Thalidomide (50mg)

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: ExperimentExperimental treatment 2 interventions
Group B: Active comparatorActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

ESS

Epistaxis Severity Score

Time frame
1,3.6.12 months after surgery
2

Hb

Hemoglobin (Hb)

Time frame
1,3,6,12months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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