Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia

• Status: Completed
• Trial end date: 2019-11-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Evolocumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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