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NCT04889430 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy
A Phase 3 study of Atypical Hemolytic-Uremic Syndrome, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
- 20
- Study locations
NCT04889430: Active Phase 3 study of Atypical Hemolytic-Uremic Syndrome, sponsored by Novartis Pharmaceuticals.
NCT04889430 is a Phase 3 study of Atypical Hemolytic-Uremic Syndrome that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 34 participants, below the 1,041-participant average among 3 other Atypical Hemolytic-Uremic Syndrome trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04889430, a Phase 3 study of Atypical Hemolytic-Uremic Syndrome, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is efficacious and safe for the treatment of aHUS in adult patients who are treatment naive to complement inhibitor therapy.
Primary Outcome
The number/percentage of participants treated with iptacopan achieving complete thrombotic microangiopathy (TMA) response during 26 weeks of study treatment. Complete TMA Response is defined as (1) hematological normalization in platelet count (platelet count ≥150 x 10\^9/L) and LDH (below ULN), and (2) improvement in kidney function (≥ 25% serum creatinine reduction from baseline), maintained for two measurements obtained at least four weeks apart, and any measurement in between
Conditions Studied
Interventions
- DRUG Iptacopan
Study Locations (20)
California
- USC Norris Cancer Center - Los Angeles
- Univ of California at Los Angeles - Los Angeles
- Univ Cali Irvine ALS Neuromuscular - Orange
- Univ of California at Sacramento - Sacramento
- Harbor-UCLA Medical Center . - Torrance
Ohio
- University of Cincinnati - Cincinnati
- Cleveland Clinic Foundation - Cleveland
- Comprehensive Transplant Ctr at OSU - Columbus
New Jersey
- St Barnabas Hospital - Livingston
- Rut Univ for Translational Med Scie - New Brunswick
New York
- Montefiore Medical Center . - The Bronx
- Montefiore Medical Center - The Bronx
District of Columbia
- Georgetown University Lombardi Cancer Center - Washington D.C.
Florida
- University Of Miami - Miami
Massachusetts
- Brigham and Womens Hospital - Boston
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-01-17 |
| Est. Completion | 2026-08-13 |
| Phase | Phase 3 |
What the registry record for NCT04889430 still lists
NCT04889430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,041-participant average among 3 other Atypical Hemolytic-Uremic Syndrome trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Atypical Hemolytic-Uremic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Iptacopan is the first listed.
NCT04889430 names 20 study sites across 12 states, led by California, Ohio, New Jersey.
Frequently Asked Questions
What is clinical trial NCT04889430 about?
NCT04889430 is a clinical study titled "Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy". The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is efficacious and safe for the treatment of aHUS in adult patients who are treatment naive to complement inhibitor therapy.
What is the current status of trial NCT04889430?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2022-01-17. Estimated completion is 2026-08-13.
What conditions does trial NCT04889430 study?
This clinical trial studies the following conditions: Atypical Hemolytic-Uremic Syndrome.
What interventions are being tested in trial NCT04889430?
The interventions under investigation include: Iptacopan (DRUG).
Who is sponsoring clinical trial NCT04889430?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04889430 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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