Loading clinical trials...
Loading clinical trials...
A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients With Homozygous Familial Hypercholesterolemia (HoFH) in India
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.
Age
12 - 80 years
Sex
ALL
Healthy Volunteers
No
Research Site
Ahmedabad, Gujarat, India
Research Site
Bangalore, Karnataka, India
Research Site
Belagavi, Karnataka, India
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
Start Date
August 4, 2018
Primary Completion Date
November 27, 2019
Completion Date
November 27, 2019
Last Updated
May 29, 2024
30
ACTUAL participants
evolocumab
DRUG
Lead Sponsor
Amgen
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions