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NCT04469465 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Alexion Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
86
Enrollment target

NCT04469465 is a Phase 3 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 86 participants.

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The verdict

NCT04469465, a Phase 3 study, has completed, sponsored by Alexion Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
86 participants
Enrollment target

Study Summary

The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.

Interventions

  • DRUG Placebo
  • DRUG Danicopan
  • DRUG C5 Inhibitor

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2020-12-16
Est. Completion 2024-01-16
Phase Phase 3

Sponsor

Alexion Pharmaceuticals

162 total trials

What the Registry Record Tells You About NCT04469465

The ClinicalTrials.gov registry entry for NCT04469465 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT04469465 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04469465 about?

NCT04469465 is a clinical study titled "Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)". The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.

What is the current status of trial NCT04469465?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2020-12-16. Estimated completion is 2024-01-16.

What interventions are being tested in trial NCT04469465?

The interventions under investigation include: Placebo (DRUG), Danicopan (DRUG), C5 Inhibitor (DRUG).

Who is sponsoring clinical trial NCT04469465?

This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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