Informations générales (source: ClinicalTrials.gov)
An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)
Interventional
Phase 3
Ionis Pharmaceuticals, Inc. (Voir sur ClinicalTrials)
décembre 2022
mars 2027
02 décembre 2025
The purpose of this study is to evaluate the safety and tolerability of olezarsen in
participants with SHTG.
Etablissements
| Etablissement | Contact | Statut | Actualisé | ||
|---|---|---|---|---|---|
| Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données | |||||
Critères
Tous
- Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an
acceptable safety profile, per Investigator judgment. Satisfactory completion
requires that the patient did not terminate early from treatment.
- Participants must be on a stable regimen of lipid-lowering therapy that should
adhere to standard of care (SOC) per local guidelines. A patient may be eligible if
their regimen of lipid-lowering therapy has been changed recently, provided that
lipid lowering medications are optimized and stabilized for at least 4 weeks prior
to the end of the Qualification Period of this OLE study; ideally, such changes are
initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6).
- A patient may re-enroll in the study after having completed the study when the
Treatment Period was 53 weeks, if the patient satisfactorily completed the study
with an acceptable safety profile, per Investigator judgment. In the case of
re-enrollment, there is no limit on the time gap between completion of treatment
under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks
between doses).
Key Exclusion Criteria:
• Have any new condition or worsening of existing condition which in the opinion of the
Investigator would make the participant unsuitable for enrollment, or could interfere
with the participant participating in or completing the study, including need for
treatment with disallowed medications, or need to change the required stable regimen as
per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria. It is acceptable to
adjust a regimen of lipid-lowering therapy as described in the second Key Inclusion
Criterion above, and it is acceptable to adjust or stop lipid-lowering therapy at or
after Week 13 per Investigator judgment.
NOTE: Other Inclusion/Exclusion criteria may apply.