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Completed

NCT Number: NCT04861090

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

The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free when lanadelumab is given every 2 and every 4 weeks.

This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH-Universitätsklinikum Klinikum Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is aged >= 12 years at the time of the last documented HAE attack in the eligibility period.
  • Participant has a physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II.
  • Participant had initiated LTP with lanadelumab during the eligibility period.
  • Participant provides informed consent or assent prior to the initiation of any study procedures (where required by local regulations).

Exclusion criteria

  • Participant was enrolled in a therapeutic investigational drug or device trial during the observation period.
  • Participant without documented HAE attacks in the pre-index period and/or without available participant diary or systematic documentation of HAE attacks in the medical records during the post index period.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Who Are Free of Hereditary Angioedema (HAE) Attacks Treated With Lanadelumab

    Time frame: Up to Month 12

    Percentage of participants who are free of HAE attacks will be reported. A HAE attack is defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).

  2. Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Two Weeks

    Time frame: Up to Month 12

    Percentage of participants who are free of HAE attacks treated with lanadelumab which was administered every two weeks will be reported.

  3. Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Four Weeks

    Time frame: Up to Month 12

    Percentage of participants who are free of HAE attacks treated with lanadelumab which was administered every four weeks will be reported.

Secondary outcomes

  1. Percentage of Participants With Specific HAE Attack Occurrence

    Time frame: Up to Month 12

    Percentage of participants with specific HAE attack occurrence (e.g. attacks of specific localization, attacks requiring on-demand medication, life-threatening attacks) will be reported.

  2. Percentage of Participants Who are Free of HAE Attacks Relative to Prior Treatment

    Time frame: Up to Month 12

    Percentage of participants who are free of HAE attacks relative to prior treatment (e.g. prior prophylaxis treatment or on-demand medications) among participants treated with lanadelumab will be reported.

  3. Number of Participants Characterized With Every Four Weeks Adjustment

    Time frame: Every 4 weeks from start of treatment (Up to Month 12)

    Number of participants will be characterized with every four weeks adjustment (e.g. weight, age, duration of disease, history of life-threating attacks, length of attack-free interval during lanadelumab treatment) will be reported.

  4. Number of Participants Characterized Based on Primary Reasons for Down Titration

    Time frame: Up to Month 12

    Number of participants will be characterized based on primary reasons for down titration will be reported.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Retrospective, Observational Chart Review Study Evaluating Clinical Effectiveness and Disease/Treatment Management Among Patients Who Initiated Long-term Prophylaxis With Takhzyro® in a Real-world Setting

Acronym: INTEGRATED

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2021
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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