Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial … (NCT03403374) | Clinical Trial Compass
CompletedPhase 4
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
India30 participantsStarted 2018-08-04
Plain-language 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.
Who can participate
Age range12 Years – 80 Years
SexALL
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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
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)