Community Cancer Trials of Utah | Ogden, UT
Status and phase
Conditions
Treatments
About
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.
Full description
This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count <30 G/L) who failed previous first-line treatment with corticosteroids.
After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion criteria
Key Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
150 participants in 3 patient groups, including a placebo group
Loading...
Central trial contact
Novartis Pharmaceuticals; Novartis Pharmaceuticals
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal