RecruitingPhase 3NCT03955445
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis
Sponsor
Novartis Pharmaceuticals
Enrollment
225 participants
Start Date
Oct 3, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis
Eligibility
Min Age: 12 YearsMax Age: 100 Years
Inclusion Criteria1
- \- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
Exclusion Criteria4
- Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study
- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
- History of HIV or any other immunodeficiency disease
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Interventions
DRUGLNP023
LNP023 capsules
Locations(50)
View Full Details on ClinicalTrials.gov
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NCT03955445
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