Status:
COMPLETED
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ravul...
Detailed Description
The study will consist of up to a 30-day Screening Period, a 10-week Randomized Treatment Period, and an Extension Period of up to 172 weeks.
Eligibility Criteria
Inclusion
- Male or female ≥18 years of age
- Treated with eculizumab for PNH for at least 3 months prior to Day 1
- LDH level ≤1.5 × upper limit of normal (ULN) at screening
- PNH diagnosis confirmed by documented high-sensitivity flow cytometry.
- Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
- Body weight ≥40 to \<100 kilogram (kg)
- Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
- Willing and able to give written informed consent and comply with study visit schedule.
Exclusion
- More than 1 LDH value \> 2 × ULN within the 3 months prior to study entry
- History of bone marrow transplantation.
- History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the Investigator or Sponsor, would preclude participation.
- Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH).
- Females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or Day 1.
- Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT03748823
Start Date
February 19 2019
End Date
August 31 2023
Last Update
September 19 2024
Active Locations (51)
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1
Research Site
Los Angeles, California, United States, 90089
2
Research Site
Liverpool, Australia, 2170
3
Research Site
Parkville, Australia, 3050
4
Research Site
Vienna, Austria, 1090