Phase 4
Completed N=30
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia HoFH
Source: ClinicalTrials.gov NCT03403374 ↗
Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 10 Participants
◆ Published Evidence
Established
32citations · ~6 / year
Evolocumab in patients with homozygous familial hypercholesterolemia in India.
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.
Linked Publications (2)
-
Evolocumab in patients with homozygous familial hypercholesterolemia in India.
-
Evolocumab Treatment in Pediatric Patients With Homozygous Familial Hypercholesterolemia: Pooled Data From Three Open-Label Studies.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.