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NCT04747613 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria
A Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
- 20
- Study locations
NCT04747613 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 208 participants, below the 250-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT04747613, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan
Conditions Studied
Interventions
- DRUG Iptacopan
Study Locations (20)
Other
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Tianjin
- Novartis Investigative Site - Tianjin
- Novartis Investigative Site - Brno-Bohunice
- Novartis Investigative Site - Lille
- Novartis Investigative Site - Nantes
- Novartis Investigative Site - Nice
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Toulouse
California
- City Of Hope - Duarte
- USC Norris Cancer Center - Los Angeles
- Univ of California Irvine (Chao Family Comprehensive Cancer Center) - Orange
São Paulo
- Novartis Investigative Site - Santo André
- Novartis Investigative Site - São Paulo
Florida
- Lakes Research - Miami Lakes
Georgia
- Augusta University - Augusta
New York
- Montefiore Medical Center - The Bronx
Ohio
- Cleveland Clinic Foundation - Cleveland
South Carolina
- Prisma Health Upstate - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2021-07-27 |
| Est. Completion | 2027-10-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04747613
The ClinicalTrials.gov registry entry for NCT04747613 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 250-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (17% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Paroxysmal Nocturnal Hemoglobinuria appearing as the primary indexed condition, and to 1 intervention - of which Iptacopan is the first listed.
NCT04747613 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, São Paulo.
Frequently Asked Questions
What is clinical trial NCT04747613 about?
NCT04747613 is a clinical study titled "Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria". This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan
What is the current status of trial NCT04747613?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2021-07-27. Estimated completion is 2027-10-19.
What conditions does trial NCT04747613 study?
This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria.
What interventions are being tested in trial NCT04747613?
The interventions under investigation include: Iptacopan (DRUG).
Who is sponsoring clinical trial NCT04747613?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04747613 being conducted?
This trial has 20 study locations across California, Florida, Georgia, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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