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Clinical Trial Details

ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

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Trial Information

Broad Health Condition Paroxysmal Nocturnal Hemoglobinuria (PNH)

Specific Health Condition

Trial FocusTreatment

Recruitment statusCompleted

Recruitment Details
Recruitment State
ACT,NSW,QLD,VIC,

Phase of TrialPhase 3

Trial summary

The primary purpose of this study was to assess the noninferiority of ravulizumab compared to
eculizumab in adult participants with PNH who were clinically stable after having been
treated with eculizumab for at least 6 months.
Eligibility

Key inclusion criteria

Inclusion Criteria:

    1. Male or female =18 years of age.

    2. Treated with eculizumab for PNH for at least 6 months prior to Day 1.

    3. Lactate dehydrogenase level =1.5 times the upper limit of normal (ULN) at screening.

    4. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry.

    5. Documented meningococcal vaccination not more than 3 years prior to, or at the time
       of, initiating study treatment.

    6. 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.

    7. Willing and able to give written informed consent and comply with study visit
       schedule.

  Exclusion Criteria:

    1. History of bone marrow transplantation.

    2. Body weight <40 kilograms at screening.

    3. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease
       that, in the opinion of the investigator or sponsor, would preclude participation.

    4. Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal
       bleeding, severe congestive heart failure, anticipated need for major surgery within 6
       months of randomization, or coexisting chronic anemia unrelated to PNH).

    5. Female participants who are pregnant, breastfeeding, or who have a positive pregnancy
       test at screening or Day 1.

    6. Participation in another interventional clinical study or use of any experimental
       therapy within 30 days before initiation of study treatment on Day 1 in this study or
       within 5 half-lives of that investigational product, whichever is greater.

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Alexion Pharmaceuticals

Trial websitehttps://clinicaltrials.gov/show/NCT03056040

Trial IDNCT03056040