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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 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.

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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.

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

FieldValue
Enrollment Target 34 participants
Start Date 2022-01-17
Est. Completion 2026-08-13
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT04889430

The ClinicalTrials.gov registry entry for NCT04889430 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,041-participant average among 3 other Atypical Hemolytic-Uremic Syndrome trials with a reported enrollment target (97% 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 Atypical Hemolytic-Uremic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Iptacopan is the first listed.

NCT04889430 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.