ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

ClinicalTrials.gov ID: NCT04469465

Public ClinicalTrials.gov record NCT04469465. 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 May 10, 2026, 2:35 PM EDT

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

Official title

A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)

Study identification

NCT ID
NCT04469465
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alexion Pharmaceuticals, Inc.
Industry
Enrollment
86 participants

Conditions and interventions

Interventions

  • C5 Inhibitor Drug
  • Danicopan Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
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
Dec 15, 2020
Primary completion
Jun 28, 2022
Completion
Jan 15, 2024
Last update posted
May 3, 2025

2020 – 2024

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Research Site Los Angeles California 90089
Research Site Weston Florida 33331
Research Site Chicago Illinois 60612
Research Site Kalamazoo Michigan 49007
Research Site New York New York 10065
Research Site Dallas Texas 75390
Research Site Milwaukee Wisconsin 53212

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 55 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04469465, 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 May 3, 2025 · Synced May 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04469465 live on ClinicalTrials.gov.

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