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Recruiting Phase 3 Interventional

Study to Assess the Pharmacokinetics, Safety, and Tolerability of Iptacopan in Pediatric PNH Patients

ClinicalTrials.gov ID: NCT06934967

Public ClinicalTrials.gov record NCT06934967. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Single-arm, Multicenter, Phase 3 Study to Assess Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric PNH Patients 2 to <18 Years of Age

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this open-label, single arm, multicenter, phase 3 study is to assess the pharmacokinetics of iptacopan in pediatric patients and to assess whether iptacopan is safe and well tolerated when used for the treatment of pediatric paroxysmal nocturnal hemoglobinuria (PNH) patients 2 to \< 18 years of age.

Study identification

NCT ID
NCT06934967
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
12 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 27, 2025
Primary completion
Oct 13, 2031
Completion
Nov 12, 2031
Last update posted
Aug 6, 2026

2025 – 2031

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Childrens Healthcare of Atlanta Atlanta Georgia 30342 Recruiting
Cancer Institute of New Jersey New Brunswick New Jersey 08901 Recruiting
Childrens Hospital of Philadelphia Philadelphia Pennsylvania 19104-4399 Recruiting
St Jude Childrens Research Hospital Memphis Tennessee 38105 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06934967, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 6, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06934967 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →