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A PHASE 2 RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF MHAA4549A,
A MONOCLONAL ANTIBODY, IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR
TREATMENT OF SEVERE INFLUENZA A INFECTION

2. OBJECTIVES2.1 SAFETY OBJECTIVESThe safety objectives for this study are as follows:* To evaluate the safety of MHAA4549A in combination with oseltamivir compared with placebo and oseltamivir in patients with severe influenza A, focusing on the…

A Phase II, global, randomized study to evaluate the efficacy and safety of Danirixin (GSK1325756) co-administered with a standard-of-care antiviral (oseltamivir), in the treatment of adults hospitalized with influenza (study 201023, DAHLIA)

Primary:To assess the efficacy of treatment with IV danirixin twice daily given with oral oseltamivir compared to oral oseltamivir twice daily on time to clinical response (TTCR)Secondary:Time to respiratory response (TTRR), clinical measures of…

A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection

Primary ObjectivesThe primary objectives are to evaluate in infants who are hospitalized with RSV infection:• the pharmacokinetics of JNJ-53718678 after multiple oral doses;• the safety and tolerability of JNJ-53718678 when administered for 7 days.…

A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.

A Phase 2b, Randomized, Controlled Trial Evaluating GS 5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is as follows:* To evaluate the effect of presatovir (GS-5806) on nasal RSV viral load in RSV positive LT recipients with acute respiratory symptomsThe secondary objectives of this study are as follows: * To…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled
Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults with Respiratory Syncytial Virus (RSV) Infection

The primary objective of this study is to evaluate the effects ofpresatovir (GS-5806) on RSV viral load in RSV-positive adults hospitalizedwith acute respiratory infectious symptoms.The secondary objectives of this study are to evaluate:- The effect…

A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study and an Open-Label Relative Bioavailability and Food Effect Study of VX-787 in Healthy Subjects

Primary: Part A:to evaluate the safety and tolerability of single oral ascending doses of VX-787 administered to healthy male and female subjects (of non-childbearing potential)Part C:to evaluate safety and tolerability of multiple oral ascending…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects with Uncomplicated Influenza.

Primary ObjectiveTo evaluate the clinical efficacy of favipiravir compared with placebo in treating adult subjects who have confirmed influenza.Secondary Objectives- To further evaluate the clinical and anti-viral effects of favipiravir.- To…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in
Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)

The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-…

A phase III, randomised, observer-blind, placebo-controlled,
multicentre, clinical trial to assess the prophylactic efficacy, safety,
and immunogenicity of GSK Biologicals* herpes zoster gE/AS01B
candidate vaccine when administered intramuscularly on a twodose
schedule to adult autologous haematopoietic stem cell
transplant (HCT) recipients.

The purpose of this study is to test how well a new vaccine works to protect against shingles in people after they have received a transplant with their own blood stem cells.

A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the
Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C
Virus Infection and Chronic Kidney Disease

Advances in the treatment of patients with hepatitis C infection have contributed to improved efficacy in several populations. However, for patients with CKD, particularly those with stages 3-5, treatment options remain limited and suboptimal. Given…

The efficacy of mepolizumab treatment on rhinovirus induced asthma exacerbations

With this project we aim to determine the efficacy of anti-IL-5 treatment (mepolizumab) on virus-induced exacerbations in allergic asthma patients.Specific research questionsDoes IL-5 neutralisation:1) reduce the inflammatory response (T cell…

A Phase I/IIa Study Assessing Single and Multiple Doses of study drug in Healthy and Genotype 1 HCV-Infected Subjects

Primary:* To evaluate safety and tolerability.* To evaluate antiviral activity.Secondary:* To evaluate plasma and urine PK.* To evaluate the effect of food on the PK of the study drug.

A Phase Ib, double-blind, randomized, placebo-controlled trial in genotype 1 HCV-infected patients to determine the safety, tolerability, pharmacokinetics and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin

1. To determine the safety and tolerability of TMC649128/TMC619688 during multiple dosing in treatmentnaïve and treatment-experienced genotype 1 HCV-infected subjects at different dose regimens as 10-days and 14-days monotherapy.2. To determine the…

A randomized, double-blind placebo- and active-controlled study of the pharmacokinetics, pharmacodynamics and safety of single ascending doses of HM10660A (LAPS-Interferon Alpha-2B) in healthy male subjects

to study the safety and tolerability of HM10660A (LAPS-interferon alpha-2b), including immunogenicity, as compared to Pegasys® (PEG-interferon alpha-2a)to study the pharmacokinetics and pharmacodynamics of HM10660A (LAPS interferon alpha-2b) as…

A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects (Part A), and in Chronic Hepatitis C Genotype 1 Infected Patients (Part B).

Primary1. To evaluate the safety, tolerability and pharmacokineticproperties of RO5428029 in healthy subjects and chronichepatitis C genotype 1 infected patients.2. To evaluate pharmacodynamics (viral load response) ofRO5428029 in chronic hepatitis…

A phase 3, randomized, double-blind study to evaluate the safety and efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 versus Ritonavir-Boosted Atazanavir plus Emitricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naive adults.

The primary objective of this study is:To evaluate the efficacy of a regimen containing elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS 9350 versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV 1…

A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection.;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 13-Mar-12)

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…

Experimental Human Rhinovirus Infection, a randomized placebo-controlled pilot study

Our primary objective is to set up the Human Rhinovirus (HRV)-model in our centre, using HRV serotype 16 (HRV-16). Secondary objectives:1. To determine the incubation period of HRV-16 infection.2. To determine the effects of HRV-16 infection on cold…

Phase I, single-centre, randomised, placebo-controlled, double-blinded study, with single ascending dose and multiple dose at maximum tolerated dose, evaluating the safety, tolerability and pharmacokinetics of ALX-0171, administered by pulmonary inhalation, in healthy male volunteers

- to determine the safety and tolerability of escalating single doses and multiple doses of ALX-0171- to evaluate the dose-limiting toxicity (DLT) level of ALX-0171 and determine the maximum tolerated dose (MTD)- to evaluate the PK of escalating…