Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
- Sponsor
- Amgen
- Study ID
- NCT03403374
- Phase
- PHASE4
- Status
- Completed
Conditions
- Homozygous Familial Hypercholesterolemia HoFH
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- evolocumab — DRUGAdministered by SC injection via autoinjector (AI)/pen
Study Details
To describe the safety and tolerability of evolocumab in participants with homozygous familial hypercholesterolemia (HoFH) in India. All participants will receive evolocumab over an 8-week period.
Key Dates
- Start date
- Aug 4, 2018
- Status verified
- May 2024
- Primary completion
- Nov 27, 2019
- Completion
- Nov 27, 2019
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: EvolocumabEvolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).
Primary Outcome Measure
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 12 weeks ]