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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-04

Study Completion Date

2019-11-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Homozygous Familial Hypercholesterolemia HoFH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evolocumab

Evolocumab 420 mg subcutaneous (SC) once monthly (QM) or every 2 weeks (Q2W; for participants on apheresis).

Group Type EXPERIMENTAL

evolocumab

Intervention Type DRUG

Administered by SC injection via autoinjector (AI)/pen

Interventions

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evolocumab

Administered by SC injection via autoinjector (AI)/pen

Intervention Type DRUG

Other Intervention Names

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Repatha® EvoMab

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No