Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia

Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia - ODYSSEY OLE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45050

Enrollment

163

Registered

2013-10-18

Start date

2014-02-13

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial hypercholesterolemia inherited disorder of lipid metabolism

Interventions

Injection at site

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Eligible patients for this OLE study will be men and women diagnosed with heFH in the parent study and who have completed one of the following studies, EFC12492, R727-CL-1112, EFC12732 or LTS11717. Patietns who mised the last injection or who perfromed the end of treatment visti outside the expected timelines can also be enrolled.

Exclusion criteria

Exclusion criteria: * Significant protocol deviation in the parent study based on the Investigator judgment, such as non-compliance by the patient. * Adverse event leading to permanent discontinuation from parent study. * Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study. * Positive pregnancy test at the end of treatment visit or end of study visit, according to the parent study the patient was originating from. * Women of childbearing potential not willing to continue highly-effective method of birth control and/or who are unwilling or unable to be tested for pregnancy.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is safety. Safety Endpoints: * Safety parameters (adverse events, laboratory data, vital signs) assessed throughout the OLE study. Primary objective * To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies: EFC12492, R727-CL-1112, EFC12732 & LTS11717.	—

Measure

Time frame

The primary endpoint of this study is safety. Safety Endpoints: * Safety parameters (adverse events, laboratory data, vital signs) assessed throughout the OLE study. Primary objective * To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies: EFC12492, R727-CL-1112, EFC12732 & LTS11717.

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Secondary

Measure	Time frame
Efficacy Endpoints of interest include: * Calculated serum LDL-C values and percent changes from baseline of the parent study (EFC 12492, R727-CL-1112, EFC 12732 or LTS11717) over time in this study. * Proportion of patients achieving an LDL-C	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)