Homozygous Familial Hypercholesterolemia (HoFH)
Conditions
Brief summary
Percent Change from Baseline to Month 12 in Fasting LDL-C
Detailed description
1. Percent Change from Baseline to Month 12 in Fasting Apolipoprotein B (ApoB), 2. Percent Change from Baseline to Month 12 in in Fasting Non-High Density Lipoprotein Cholesterol (non-HDL-C), 3. Change from Baseline to Month 12 in Fasting LDL-C, 4. Area Under the Plasma Concentration Versus the Time Curve (AUC) from Baseline to Month 12 for Fasting LDL-C, 5. Percent Change from Baseline to Month 12 in Fasting Triglycerides (TGs), 6. Percent Change from Baseline to Month 12 in Fasting Angiopoietin-like Protein 3 (ANGPTL3), 7. Percent Change from Baseline to Month 12 in Fasting Total Cholesterol, 8. Percent Change from Baseline to Month 12 in in Fasting HDL-C, 9. Number of Participants who Meet European Union (EU) LDL-C Apheresis Eligibility Criteria (per German Apheresis Working Group) at Month 12, 10. Number of Participants who Meet United States (US) Apheresis Eligibility Criteria (per National Lipid Association) at Month 12, 11. Number of Participants with Fasting LDL-C <100 mg/dL at Month 12, 12. Change from Baseline in Fasting LDL-C Over Time, 13. Percent Change from Baseline in Fasting LDL-C Over Time, 14. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline to Month 12 in Fasting LDL-C | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent Change from Baseline to Month 12 in Fasting Apolipoprotein B (ApoB), 2. Percent Change from Baseline to Month 12 in in Fasting Non-High Density Lipoprotein Cholesterol (non-HDL-C), 3. Change from Baseline to Month 12 in Fasting LDL-C, 4. Area Under the Plasma Concentration Versus the Time Curve (AUC) from Baseline to Month 12 for Fasting LDL-C, 5. Percent Change from Baseline to Month 12 in Fasting Triglycerides (TGs), 6. Percent Change from Baseline to Month 12 in Fasting Angiopoietin-like Protein 3 (ANGPTL3), 7. Percent Change from Baseline to Month 12 in Fasting Total Cholesterol, 8. Percent Change from Baseline to Month 12 in in Fasting HDL-C, 9. Number of Participants who Meet European Union (EU) LDL-C Apheresis Eligibility Criteria (per German Apheresis Working Group) at Month 12, 10. Number of Participants who Meet United States (US) Apheresis Eligibility Criteria (per National Lipid Association) at Month 12, 11. Number of Participants with Fasting LDL-C <100 mg/dL at | — |