14 results
To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as…
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
Primary Objective:The primary objective for this study is to evaluate, in treatment-naive subjects with chronic HCV GT-2 or -3 infection:* SVR12 following 24 weeks of treatment with Lambda/RBV and the SVR12 following 24 weeks of treatment with alfa-…
To assess the PD, PK and safety of the Zoreline 10.8 mg goserelin subcutaneous (SC) implant.
Primary objective:•To assess the effect of multiple dose daclatasvir (60mg QD) on the pharmacokinetics (AUC, Cmax, Ctrough, CLr) of multiple dose metformin (1,000mg BID) by intra-subject comparison, in healthy subjects.Secondary objective:•To assess…
Primary objective:To compare the effect of multiple dose atazanavir/cobicistat on the multiple dose phar-macokinetics of daclatasvir with the effect of atazanavir/ritonavir on the multiple dose of daclatasvir by intra-subject comparison in healthy…
Primary ObjectiveTo assess the efficacy based on the proportion of subjects with SVR12, defined as HCV RNAgenotype 1 who are prior non-responders to pegIFNα-2a/RBV.Secondary Objectives• To assess efficacy, as determined by the proportion of subjects…
Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…
Primary objectiveThe primary objective for this study is to analyse the impact of inhibition of viral replication by interferon-free therapy consisting of Sofosbuvir and Daclatasvir (±Ribavirin) on the phenotype and function of the innate immune…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
The primary objective is to determine in which percentage of patients with prostate cancer with an indication for ADT, it is safe to extend the dosing interval of goserelin 10,8 mg by four weeks, before the 4th injection, using a testosterone based…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…