Status:
COMPLETED
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
Lead Sponsor:
Amgen
Conditions:
Homozygous Familial Hypercholesterolemia HoFH
Eligibility:
All Genders
12-80 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Male or female ≥ 12 to ≤ 80 years of age at the time of signing the informed consent
- Diagnosis of HoFH based on low-density lipoprotein cholesterol (LDL-C), familial history and xanthoma
- On a low-fat diet and receiving background lipid-lowering therapy stable for 4 weeks prior to screening and during the time frame of the trial
- Fasting LDL-C at screening \> 130 mg/dL (3.4 mmol/L)
- Fasting triglycerides at screening ≤ 400 mg/dL (4.5 mmol/L)
Exclusion
- Use of mipomersen or lomitapide within 6 months of screening.
- Known active infection or major hematologic, renal, metabolic, gastrointestinal, hepatic, or endocrine dysfunction
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies)
- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed
- Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception
- Subject has known sensitivity to any of the products to be administered during dosing
- History or evidence of any other clinically significant disorder, condition or disease
- Subject has previously received evolocumab or any other proprotein convertase subtilisin/kexin type 9 (PKSK-9)-inhibiting therapy
Key Trial Info
Start Date :
August 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03403374
Start Date
August 4 2018
End Date
November 27 2019
Last Update
May 29 2024
Active Locations (12)
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1
Research Site
Ahmedabad, Gujarat, India, 380 054
2
Research Site
Bangalore, Karnataka, India, 560 017
3
Research Site
Belagavi, Karnataka, India, 590010
4
Research Site
Kochi, Kerala, India, 682 027