5 results
Comparison of steady-state cysteamine-trough WBC cystine levels between Cystagon® and RP103 over 3 months for each treatment period.
I) Is the infusion of crystalloid fluids in healthy subjects associated with a reduction in microcirculatory perfused vessel density and increase in perfused boundary region? II) Does colloid administration attenuates the crystalloid-induced…
To study whether in women with EP with low but plateauing serum hCG concentrations treatment with systemic methotrexate in a single dose intramuscular regimen is superior over expectant management in terms of treatment success, future pregnancy,…
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…