An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia (SHTG)

Conditions

Severe Hypertriglyceridemia (SHTG)

Brief summary

Proportion of Patients With Change in Laboratory Values From Baseline to Week 53, and from Baseline to Week 105, and from Baseline to Week 157. Values include platelet count value <50,000 mm^3, Clinical bleeding events, decrease in eGFR by 30%, decrease in eGFR by ≥ 50%, urine protein/creatinine ratio (UPCR) ≥1000 mg/g, urine/albumin creatinine ratio (UACR) ≥500 mg/g, ALT or AST ≥5 × upper limit of normal (ULN), total bilirubin ≥2.0 mg/dL, and ALT or AST ≥3 × ULN and total bilirubin ≥2 × ULN., Proportion of Participants Who Experience Adverse Events (AEs) [Time Frame: Up to 170 weeks], Proportion of Participants Who Use Concomitant Medications [Time Frame: Up to 170 weeks]

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGISIS 678354

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of Patients With Change in Laboratory Values From Baseline to Week 53, and from Baseline to Week 105, and from Baseline to Week 157. Values include platelet count value <50,000 mm^3, Clinical bleeding events, decrease in eGFR by 30%, decrease in eGFR by ≥ 50%, urine protein/creatinine ratio (UPCR) ≥1000 mg/g, urine/albumin creatinine ratio (UACR) ≥500 mg/g, ALT or AST ≥5 × upper limit of normal (ULN), total bilirubin ≥2.0 mg/dL, and ALT or AST ≥3 × ULN and total bilirubin ≥2 × ULN., Proportion of Participants Who Experience Adverse Events (AEs) [Time Frame: Up to 170 weeks], Proportion of Participants Who Use Concomitant Medications [Time Frame: Up to 170 weeks]	—

Measure

Time frame

Proportion of Patients With Change in Laboratory Values From Baseline to Week 53, and from Baseline to Week 105, and from Baseline to Week 157. Values include platelet count value <50,000 mm^3, Clinical bleeding events, decrease in eGFR by 30%, decrease in eGFR by ≥ 50%, urine protein/creatinine ratio (UPCR) ≥1000 mg/g, urine/albumin creatinine ratio (UACR) ≥500 mg/g, ALT or AST ≥5 × upper limit of normal (ULN), total bilirubin ≥2.0 mg/dL, and ALT or AST ≥3 × ULN and total bilirubin ≥2 × ULN., Proportion of Participants Who Experience Adverse Events (AEs) [Time Frame: Up to 170 weeks], Proportion of Participants Who Use Concomitant Medications [Time Frame: Up to 170 weeks]

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Countries

Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed