Phase 4
N=30
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia HoFH
Bottom Line
View on ClinicalTrials.gov: NCT03403374 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- evolocumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
10 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) |
-6.4 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB) |
-6.0 | — |
| SECONDARY Percent Change From Baseline to Week 12 in Lipoprotein(a) (Lp[a]) |
-0.2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03403374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.