8 results
To assess the bioequivalence of two marketed formulations of ribavirin (ribavirin solution and capsules).
In the current phase 2 study we will investigate the efficacy of the combination of fulvestrant and alpelisib directly after progression on 1st or 2nd line therapy with fulvestrant with or without a CDK 4/6 inhibitor in patients with HR+HER2-…
Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with a response at Week 24 in at least one of the following groups:* Group 1 (>= 18 yr-old)* Group 2 (6 - 17 yr…
(Protocol Am2 dd. 20-Feb-2014, p17/93)The primary objectives of this study are:- To evaluate the safety of sofosbuvir (SOF) 200 mg or 400 mg + ribavirin (RBV) for 24 weeks as assessed by review of the accumulated safety data in each treatment arm-…
To investigate the effect of cholic acid supplementation on the clinical and biochemical parameters of Zellweger spectrum disorder
The purpose of the study is to determine whether treatment with alpelisib in combination with olaparib can delay the time to cancer progression compared to standard-of-care chemotherapy in participants with your type of ovarian cancer known as…
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…
Investigating the long-term safety of personalized cholic acid treatment in patients with defects in bile acid synthesis based on clinical and biochemical parameters.