Hepatitis B Clinical Trials

This is a Phase I double-blind, randomized, placebo controlled trial (1:4 ratio of placebo to vaccine) of Hepatitis E virus vaccine containing a 239 amino acid subfragment of Hecolin(R) (HEV-239) in 25 US males and non-pregnant females ages 18 - 45 (inclusive) to assess the safety, reactogenicity, and immunogenicity of ...

PRIMARY OBJECTIVES: I. To determine the objective response rate (complete response + partial response) of cabozantinib-s-malate (XL184) in children and young adults. II. To estimate whether XL184 therapy either improves the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to a historical Childrens Oncology ...

The specific aims of the study are as follows: Aim 1. Impact of HCV Cure on CNS Outcomes. Determine how curing HCV without IFN alters CNS outcomes in substance users with chronic HCV disease. Aim 2. Correlates of CNS Outcomes. Determine the viral and host correlates of Aim 1's neurocognitive ...

The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919

The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea prescribing information for Harvoni, in routine clinical practice in Korea and to report the results to the Ministry of Food ...

The trial will be conducted in two parts, dose escalation and dose expansion. AZD5153 will be investigated as a monotherapy and in combination with olaparib. AZD5153 monotherapy (dose escalation): This part of the study will enroll patients with advanced solid malignancies, including lymphoma, and test safety and tolerability of AZD5153 ...

This is a prospective, open-label, single-arm study evaluating the safety and efficacy of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta.

Each subject will be given a single oral dose of rosuvastatin on Day 1 in Period 1. In Period 2, after a washout period of at least 5 days, each subject will receive oral doses of tafamidis twice daily (BID) on days 1 and 2, followed by tafamidis once daily ...

This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will ...

This is a prospective, randomized study in which subjects lost to follow-up with positive HCV antibodies without RNA request or positive RNA will be proposed to be brought back into care. After patients identification from data files of laboratory and microbiology charts using three different cohorts in time (2005-07, 2011-11 ...