Study Description
The purpose of this open-label, single arm, multicenter extension study is to evaluate
the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who
have completed the ORION-16 or ORION-13 studies. This is an open-label, single arm, multicenter study designed to evaluate long-term
safety and tolerability of inclisiran. In addition, the study will provide participants
the opportunity to have continued access to treatment with inclisiran.
Interventions
Inclisiran
Eligibility Criteria
Key inclusion:
- Male and female participants with a diagnosis of HeFH or HoFH who completed the
ORION-16 or ORION-13 studies
- Per investigator's clinical judgment, participant derived benefit from treatment
with inclisiran in the ORION-16 or ORION-13 studies
Key exclusion:
- Participants who in the feeder inclisiran ORION-16 and ORION-13 studies either
screen failed or permanently discontinued from the treatment/study for any reason or
had serious safety or tolerability issues related to inclisiran treatment
- Any uncontrolled or serious disease, or any medical, physical, or surgical
condition, that may either interfere with participation in the clinical study or
interpretation of clinical study results, and/or put the participant at significant
risk
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.