CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Danicopandrug
Likely dose
Danicopan oral dose (multiple doses over ≥28 days); specific dose not statedAI-extracted
Key inclusion· 6
  • ✓Untreated PNH with PNH Type III erythrocyte and/or granulocyte clone size ≥10%
  • ✓Anemia with hemoglobin <12 grams/deciliter
  • ✓Adequate reticulocytosis as determined by the Investigator
  • ✓LDH ≥1.5 times the upper limit of normal
Key exclusion· 7
  • ✕History of major organ transplant (heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant
  • ✕Prior eculizumab at any dose or interval within 75 days before study entry
  • ✕Known or suspected complement deficiency
  • ✕Active bacterial or clinically significant active viral infection, body temperature >38°C, or other evidence of infection on Day 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03053102
NCT03053102Phase 2Completed
CompareCT.gov

A Phase 2 Open-Label Proof of Concept Study to Assess the Efficacy, Safety, and Pharmacokinetics of ACH-0144471 in Untreated Patients With Paroxysmal Nocturnal Hemoglobinuria

Alexion Pharmaceuticals, Inc.·interventional·Posted Feb 14, 2017·Updated Jun 23, 2022

In Brief

A Phase 2 clinical trial evaluating Danicopan for Paroxysmal Nocturnal Hemoglobinuria (PNH). Completed, enrolled 10 participants across 5 sites in 4 countries.

Detailed Summary

The purpose of this study was to determine the safety and efficacy of ACH-0144471 (also known as danicopan and ALXN2040) in currently untreated participants with PNH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria (PNH)
CountriesItaly, New Zealand, South Korea, United Kingdom
CollaboratorsAchillion, a wholly owned subsidiary of Alexion

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 14, 2017
Enrollment StartMar 31, 2017
Primary CompletionNov 14, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.4 years ago

Interventions

Danicopandrug

Danicopan was administered as multiple oral doses over a period of at least 28 days.