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Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
NCT03748823 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 3 months prior to study entry.
Conditions Studied
Interventions
- BIOLOGICAL Ravulizumab
- COMBINATION_PRODUCT Ravulizumab OBDS
Study Locations (20)
Other
- Research Site — Liverpool
- Research Site — Parkville
- Research Site — Vienna
- Research Site — Antwerp
- Research Site — Brussels
- Research Site — Hasselt
- Research Site — Leuven
- Research Site — Botucatu
- Research Site — Ribeirão Preto
- Research Site — Rio de de Janeiro
- Research Site — Salvador
- Research Site — São Paulo
- Research Site — São Paulo
- Research Site — Helsinki
- Research Site — Amiens
- Research Site — Brest
- Research Site — Lille
- Research Site — Montpellier
California
- Research Site — Los Angeles
Ontario
- Research Site — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2019-02-19 |
| Est. Completion | 2023-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03748823
The ClinicalTrials.gov registry entry for NCT03748823 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 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 109 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 Ravulizumab 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: NCT03748823 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Ontario. 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 NCT03748823 about?
NCT03748823 is a clinical study titled "Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab". The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 3 months ...
What is the current status of trial NCT03748823?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2019-02-19. Estimated completion is 2023-08-31.
What conditions does trial NCT03748823 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 NCT03748823?
The interventions under investigation include: Ravulizumab (BIOLOGICAL), Ravulizumab OBDS (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03748823?
This trial is sponsored by Alexion Pharmaceuticals, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03748823 being conducted?
This trial has 20 study locations across California, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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