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A Single-center Retrospective Study on the Clinical Characteristics of Patients with Hereditary Angioedema and the Therapeutic Effect of Lanadelumab

A Single-center Retrospective Study on the Clinical Characteristics of Patients with Hereditary Angioedema and the Therapeutic Effect of Lanadelumab

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098307
Enrollment
Unknown
Registered
2025-03-05
Start date
2025-01-16
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema

Interventions

treatment with Lanadelumab group:NA

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. According to the diagnostic criteria for HAE in Expert Consensus on the Diagnosis and Treatment of Hereditary Angioedema: (1) Clinical manifestations: recurrent skin and mucous membrane edema without response to antihistamines, glucocorticoids and epinephrine; (2) Family history: About 75% of patients had a family history of similar symptoms; (3) C1-INH and complement detection: In patients with HAE type 1, the concentration and function of serum complement C4 and C1-INH were low; In type 2 patients, the serum complement C4 and C1-INH function is low, but the concentration of C1-INH is normal or slightly increased. The level of serum C4, concentration and function of C1-INH were normal in patients with HAE-nC1-INH type. (4) For patients with HAE-nC1-INH, genetic testing is needed to make a clear diagnosis. 2. Able to understand the study method, willing to cooperate with the researchers, complete the follow-up prescribed by the study protocol, and voluntarily accept the disease-related questionnaire;

Exclusion criteria

Exclusion criteria: 1. Non-hae patients, including patients with allergic angioedema and acquired angioedema; 2. Those who are unwilling to participate in the follow-up required by the study protocol and voluntarily accept the disease-related questionnaire;

Design outcomes

Primary

MeasureTime frame
Attacks of angioedema;

Secondary

MeasureTime frame
Angioedema Control Test (AECT);Angioedema Quality of Life (AE-QoL) Questionnaire,;Hospital Anxiety and Depression Scale (HADS);post-treatment adverse reactions;

Countries

China

Contacts

Public ContactXu Yanhua

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

11059@renji.com+86 21 53882294

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026