2 results
Approved WMOCompleted
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
Approved WMOCompleted
To assess the safety and tolerability of MHS552 of single i.v./s.c. doses. Cohort 1-5 will be i.v. and cohort 6-8 will be s.c. In addition, in each of the 5 first cohorts, a sentinel group is included.