A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-20

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.

One of the main aims of this study is to learn about the number of HAE attacks in 1 month in Chinese persons with HAE during their treatment with lanadelumab. The other main aim is to learn how much time is needed to resolve acute HAE attacks when treated with icatibant. Other aims of this study are to learn more about side effects of lanadelumab and icatibant treatment as well as to collect additional information on the treatment with lanadelumab, such as the dose and how often it needs to be given, reasons for stopping the treatment with lanadelumab and how long it was taken until stopping. Participants will be treated by their doctors according to routine medical practice. Only data already available in the medical records of the participants will be reviewed and collected during this study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis

NCT04861090

Hereditary Angioedema (HAE)

COMPLETED

A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)

NCT05460325

Hereditary Angioedema (HAE)

COMPLETED PHASE3

A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America

NCT03845400

Hereditary Angioedema (HAE)

COMPLETED

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

NCT05469789

Hereditary Angioedema (HAE)

ACTIVE_NOT_RECRUITING

A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II

NCT04130191

Hereditary Angioedema (HAE)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hereditary Angioedema (HAE)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group L: Lanadelumab

Participants with HAE who have used only lanadelumab during the study-level retrospective observation period will be observed retrospectively from the start date of the participant-level overall baseline period until the end of participant-level retrospective observation period.

No intervention

Intervention Type OTHER

This is a non-interventional study.

Group I: Icatibant

Participants with HAE who have used only icatibant during the study-level retrospective observation period will be observed retrospectively from the start date of the participant-level overall baseline period until the end of participant-level retrospective observation period.

No intervention

Intervention Type OTHER

This is a non-interventional study.

Group B: Lanadelumab + Icatibant

Participants with HAE who have used both lanadelumab and icatibant during the study-level retrospective observation period will be observed retrospectively from the start date of the participant-level overall baseline period until the end of participant-level retrospective observation period.

No intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chinese participants who have received at least one dose of lanadelumab or icatibant from the lanadelumab NMPA approval date (02-Dec-2020) to the date of the day before the 1st site initiation date.
* Informed consent will be obtained from the participant (and/or a legally authorized representative) prior to including that participant as a study participant and accessing that participant's data, except for cases in which the informed consent can be waived by the site.

Exclusion Criteria

• Participation in other interventional studies involving lanadelumab, icatibant, or any other HAE drug or investigational product on or after the date of the participant's lanadelumab or icatibant initiation.

Eligible Sex

ALL

Accepts Healthy Volunteers

No