5 results
Primary Objective: • Evaluate the treatment effect of NGM282 as measured by the mean change in alkaline phosphatase (ALP) from Baseline to Week 12 in patients with PSC.Secondary Objectives:• Assess the safety and tolerability of NGM282 in patients…
The main objective of the study is to determine time to progression of the primary malignancy (locally advanced or metastatic) in patients treated with ILuP and pulmonary metastasectomy. Secondary objectives are to assess pulmonary toxicity by…
- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…
The purpose of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered a GONAL-f® dose determined according to a calculator system versus a given standard GONAL-f® dose of 150 International Unit…
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.