Skip to content

A multicenter, single arm, open-label trial to evaluate efficacy and safety of oral, twice daily iptacopan in adult PNH patients who have Hb≥10 g/dL in response to anti-C5 antibody and switch to iptacopan

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502148-10-00
Acronym
CLNP023C12303
Enrollment
25
Registered
2023-09-19
Start date
2023-10-10
Completion date
2024-10-17
Last updated
2024-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Brief summary

Measuring change in hemoglobin levels before start of iptacopan treatment and mean of hemoglobin levels at Day 126 and Day 168

Detailed description

Measuring change in hemoglobin levels before start of iptacopan treatment and mean of hemoglobin levels at Day 126 and Day 168

Interventions

DRUGIPTACOPAN

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Measuring change in hemoglobin levels before start of iptacopan treatment and mean of hemoglobin levels at Day 126 and Day 168

Secondary

MeasureTime frame
Measuring change in hemoglobin levels before start of iptacopan treatment and mean of hemoglobin levels at Day 126 and Day 168

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026