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Study Complete
Sponsor ID
20170199

Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants with Homozygous Familial HypercholesterolemiaRAMAN

Sponsor ID
20170199
Clinicaltrials.gov ID
NCT03403374
EUCTIS ID
N/A
EudraCT ID
2020‐005111‐51
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
30
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants With Treatment-Related Adverse Events (TEAEs)

Timeframe: 12 weeks

Secondary Outcome Measures

Percent Change From Baseline to Week 12 in LDL-C

Timeframe: baseline, week 12

Percent Change From Baseline to Week 12 in ApoB

Timeframe: baseline, week 12

Percent Change From Baseline to Week 12 in Lp(a)

Timeframe: baseline, week 12

Locations

Location
Status
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Location
Research Site
Pune, Maharashtra, India, 411 006
Status
Recruiting
Location
Research Site
Ahmedabad, Gujarat, India, 380 054
Status
Recruiting
Location
Research Site
Pune, Maharashtra, India, 411 005
Status
Recruiting
Location
Research Site
Belagavi, Karnataka, India, 590010
Status
Recruiting
Location
Research Site
Mumbai, Maharashtra, India, 400 007
Status
Recruiting
Location
Research Site
Bangalore, Karnataka, India, 560 017
Status
Recruiting
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Study Info
Age
12 - 80 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Aug 2018 - Nov 2019
    Inclusion and Exclusion 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