ong-term efficacy, safety and tolerability of LNP023 in C3G

Phase 1

• Conditions: C3 Glomerulopathy; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-004253-24-GB
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-20
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Patients must have completed the treatment period of the CLNP023X2202 trial on study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•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 of human immunodeficiency virus (HIV) or any other
immunodeficiency disease.
•History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified