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.
An open-label, multicentre, phase 4 study to describe the safety and tolerability of evolocumab in 30 Indian participants with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Participants will receive evolocumab 420 mg subcutaneous (SC) once monthly (QM) and study visits will occur approximately every 4 weeks. Apheresis participants will receive evolocumab 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of evolocumab (for all participants) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered by SC injection via autoinjector (AI)/pen
Research Site
Ahmedabad, Gujarat, India
Research Site
Bangalore, Karnataka, India
Research Site
Belagavi, Karnataka, India
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Includes both serious and non-serious adverse events (AEs). AE: any untoward medical occurrence in a participant. SAE: an AE that meets 1 on the following serious criteria: fatal; life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. TEAE: any AE starting on or after the first dose of study drug and up to and including 30 days after the end of study drug or the end of study date, whichever is earlier.
Time frame: 12 weeks
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: baseline, week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
Time frame: baseline, week 12
Percent Change From Baseline to Week 12 in Lipoprotein(a) (Lp[a])
Time frame: baseline, week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Kochi, Kerala, India
Research Site
Mumbai, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
New Delhi, National Capital Territory of Delhi, India
Research Site
New Delhi, National Capital Territory of Delhi, India
Research Site
New Delhi, National Capital Territory of Delhi, India
...and 2 more locations