Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03818607 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
A Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
- 20
- Study locations
NCT03818607 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria that has completed, run by Amgen. The registered enrollment target is 42 participants, below the 262-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT03818607, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
Conditions Studied
Interventions
- DRUG Eculizumab
- DRUG ABP 959
Study Locations (20)
Other
- Fakultní Nemocnice Olomouc - Olomouc
- Fakultní Nemocnice Ostrava - Ostrava-Poruba
- Keski-Suomen keskussairaala Jyväskylä - Jyväskylä
- Päijät-Häme Central Hospital - Lahti
- Saint James's Hospital - Dublin
- Azienda Ospedaliera S. Croce e Carle Cuneo - Cuneo
- Azienda USL della Romagna - Ravenna
- Fondazione Policlinico Universitario Agostino Gemelli - Roma
- Oslo University Hospital - Rikshospitalet - Oslo
- Instituto Português de Oncologia do Porto Francisco Gentil - Porto
- Univerzitetni klinični center Ljubljana - Ljubljana
- Hospital Universitario de Salamanca - Salamanca
- Hospital Universitario La Fe - Valencia
- Karolinska Universitetssjukhuset - Huddinge - Stockholm
Georgia
- Children's Healthcare of Atlanta at Egleston - Atlanta
Jihormoravsky KRAJ
- Fakultní Nemocnice Brno - Brno
Brittany Region
- Hôpital Privé Sévigné - Cesson-Sévigné
Forli-cesena
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - Meldola
Monza Brianza
- Azienda Ospedaliera San Gerardo di Monza - Monza
Gelderland
- Radboud Universitair Medisch Centrum - Nijmegen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-01-22 |
| Est. Completion | 2022-07-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03818607
The ClinicalTrials.gov registry entry for NCT03818607 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 262-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (84% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Paroxysmal Nocturnal Hemoglobinuria appearing as the primary indexed condition, and to 2 interventions - of which Eculizumab is the first listed.
NCT03818607 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Georgia, Jihormoravsky KRAJ.
Frequently Asked Questions
What is clinical trial NCT03818607 about?
NCT03818607 is a clinical study titled "A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH". This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
What is the current status of trial NCT03818607?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2019-01-22. Estimated completion is 2022-07-12.
What conditions does trial NCT03818607 study?
This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria.
What interventions are being tested in trial NCT03818607?
The interventions under investigation include: Eculizumab (DRUG), ABP 959 (DRUG).
Who is sponsoring clinical trial NCT03818607?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03818607 being conducted?
This trial has 20 study locations across Georgia, Jihormoravsky KRAJ, Brittany Region, Forli-cesena, Monza Brianza. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Paroxysmal Nocturnal Hemoglobinuria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
RECRUITING · Phase 3
-
A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH
ACTIVE NOT RECRUITING · Phase 3
-
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
ACTIVE NOT RECRUITING · Phase 3
-
Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Ravulizumab (ALXN1210) in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria
COMPLETED · Phase 3
-
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
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.