4 results
(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-…
Primary:* To determine the efficacy of PSI-7977 in combination with RBV administered for 12 weeks compared with PEG/RBV administered for 24 weeks in treatment-naïve patients with HCV genotype 2 or 3 as assessed by the rate of SVR12 (HCV RNA of…
To determine the efficacy of 3 different Hepatitis B vaccines (HBVAXPRO 40 micrograms, Fendrix and Twinrix) in Hepatitis B vaccine non-responders (ant-HBsAg < 10 IU/L) after one (standard) series of Hepatitis B vaccination with HBVAXPRO-10…
The objectives of Part B of the study are as follows: Primary: To assess the safety and tolerability of CALY-002 following multiple ascending doses administered IV in subjects with coeliac disease (CeD). Secondary: (1) To characterise the PK of CALY…