Familial Hypercholesterolaemia, Hypercholesterolaemia
Conditions
Keywords
familial hypercholesterolaemia, hypercholesterolaemia, FH, HoFH, Leqvio, inclisiran sodium
Brief summary
The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice
Detailed description
Uncontrolled, central registration system, multicenter, special drug use-results surveillance. This is a prospective, open-label, multicenter, single-arm observational study (non-interventional study: NIS) conducted only in Japan. The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio. Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio, whichever comes earlier.
Interventions
OTHERinclisiran
Prospective observational study. There is no treatment allocation. Patients prescribed with inclisiran are eligible to enroll into this study.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients who provided written informed consent to participate in this survey prior to the start of treatment with Leqvio. * Patients who received treatment with Leqvio as per the package insert.
Exclusion criteria
* Patients who received treatment with a formulation containing the same ingredients as Leqvio in the past. * Patients participating in other interventional studies at the time of informed consent. * Patients planning to participate in other interventional studies during this survey.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | Up to 24 months | To evaluate the long-term safety profile of Leqvio |
| Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions | Up to 24 months | To evaluate the long-term safety profile of Leqvio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events leading to discontinuation of treatment with the product | Up to 24 months | To evaluate the tolerability of Leqvio |
| Percent change from baseline in LDL-C levels | Month 24 | To evaluate the efficacy of Leqvio based on LDL-C levels |
Countries
Japan
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed