Prophylaxis Impact on Quality of Life Impariment of HAE Patients with Lower Annual Base Attack Rates
- Conditions
- D84.1Defects in the complement system
- Registration Number
- DRKS00028582
- Lead Sponsor
- Takeda GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
Confirmed diagnosis of HAE Type 1/2.
- Voluntarily provision of written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study.
- Initiation of treatment with lanadelumab in accordance with current product labelling.
- Documented history of = 24 attacks in the year prior to enrollment AND baseline AE-QoL Score of = 30 points.
- 12 years or older.
- Inability to provide written, signed, and dated informed consent.
- Documented history of > 24 confirmed HAE attacks/year in the year prior to study enrollment OR baseline AE-QoL Score of < 30 points.
- Participation in the study ruled out by the treating physician/investigator.
- Pregnant or breastfeeding.
- Current or planned participation in interventional studies.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method