10
Participants
Start Date
April 28, 2021
Primary Completion Date
August 31, 2024
Study Completion Date
August 31, 2024
Cladribine 10 mg oral tablet
Cladribine tablets (Mavenclad®, Merck KGaA, Darmstadt, Germany) will be given according to the label with a cumulative dose of 3.5 mg/kg body weight distributed over 2 years as one treatment course of 1.75 mg/kg per year. Each treatment course will consist of 2 weeks of treatment, one at the beginning of the first month and one at the beginning of the second month of the respective year of treatment. Each treatment week will consist of 4 or 5 days in which the participant will receive 10 mg or 20 mg (1 or 2 tablets, respectively) as a single daily dose, depending on body weight, according to the tables available in label. Upon completion of the two treatment courses, no further courses will be required in years 3 and 4.
Pontifical Catholic University of Rio Grande do Sul, Porto Alegre
Merck S.A., Brazil, an affiliate of Merck KGaA, Darmstadt, Germany
UNKNOWN
Pontificia Universidade Católica do Rio Grande do Sul
OTHER