A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals
About this trial
This is a post-marketing surveillance study conducted as part of the Risk Management Plan (RMP) for South Korea, to evaluate the safety and effectiveness of iptacopan in real-world clinical settings for the treatment of either PNH or C3G in Korean patients. Prospective data will be collected from patient medical records to address the objectives for all eligible populations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older who have been diagnosed with PNH or C3G.
Patients who have received vaccination in accordance with the approved Korean labeling prior to initiating treatment with iptacopan.
Patients who are being treated or will be treated with iptacopan in accordance with the approved Korean labeling.
Patients who have voluntarily provided consent for study participation (written informed consent).
Disqualifiers
Patients who fall under the contraindications for iptacopan administration according to approved Korean labeling.
Patients for whom iptacopan administration is deemed inappropriate based on the investigator's judgment.
Trial population
Adult patients in South Korea who receive iptacopan for the treatment of PNH or C3G during routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
21 Participants
are grouped into 2 trial groupsGroup A: PNH Cohort
Group B: C3G Cohort
Trial outcomes
Primary outcomes
1
Incidence Rate of Adverse Events (AE), Serious Adverse Events (SAE), and Adverse Drug Reactions (ADR)
Incidence rate of all AE/ADR, SAE/serious adverse drug reactions (SADR), unexpected AE/ADR, and unexpected SAE/SADR that occur after the administration of iptacopan.
Time frame
Up to 2 yearsSecondary outcomes
1
Hemoglobin Levels
Time frame
Baseline and Week 242
Lactate Dehydrogenase (LDH) levels
Time frame
Baseline and Week 243
White Blood Cell Count (WBC)
Time frame
Baseline and Week 244
Red Blood Cell Count (RBC)
Time frame
Baseline and Week 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov