Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
NCT03818607 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03818607 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Georgia, Jihormoravsky KRAJ. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03818607?
The interventions under investigation include: Eculizumab (DRUG), ABP 959 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03818607?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.