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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: Completed Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Amgen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).
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 |
What the finished NCT03818607 record still lists
NCT03818607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 262-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (84% lower).
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 names 20 study sites across 7 states, led by 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
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Where NCT03818607's enrollment target sits among peer trials
42 13th of 14 higher than 2 of 14 other Paroxysmal Nocturnal Hemoglobinuria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Nocturnal Hemoglobinuria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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-
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