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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 randomised, double-blind, placebo-controlled, single-centre phase IIb trial as part of the EU-funded UNISEC project to assess the immunogenicity and safety of different formulations and dosing regimens of FLU-v vaccine administered subcutaneously in healthy adults aged 18-60 years.

To investigate the safety of the vaccination and the immune responses generated by the different formulations and dosing regimens of FLU-v in healthy adults.

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…

The effects of BCG-vaccination on the immune response induced by influenza-vaccination in healthy volunteers. A pilot proof-of-principle study.

Primary objective: The primary objective of the study is to determine the effects of BCG-vaccination on the immune response induced by subsequent influenza vaccination in healthy volunteers. This will be determined by measuring the Th1/Th2 response…

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…

Randomized double blind placebo controlled PK/PD study on the effects of a single intravenous dose of NOX-H94 on serum iron during experimental human endotoxemia

Primary Objective•To assess the pharmacodynamic response after single dose administration of NOX H94 in healthy subjects during experimental endotoxemia.Secondary Objective• To determine the pharmacodynamic effects of NOX H94 after single dose…

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 two-part, randomized, double-blind, placebo-controlled, single-center study to evaluate the safety and causal prophylactic efficacy of KAF156 in a controlled human malaria challenge model

This is a two part proof of efficacy study of KAF156 as a causal prophylactic agent in malaria. Results will be used to guide dose selection for further development of KAF156 in patients.

An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis versus Placebo in High Risk Surgical Subjects with Intra-abdominal Infections - A Multicentre, Randomized, Double-Blind Study

Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (miravirsen) Administered to Treatment-Naïve Subjects with Chronic Hepatitis C (CHC) Infection

Main objectiveTo determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with CHC.Secondary objectivesTo assess the pharmacokinetics (PK) of multiple dosing of miravirsen administered subcutaneously to subjects…

A Phase-II, double-blind, randomized, placebo-controlled study on the safety and early efficacy of Alkaline Phosphatase in sepsis patients with Renal Failure.

To establish the safety and and tolerability and early efficacy of Alkaline phosphatase in the treatment of sepsis patients with renal failure.

Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle.

Primary objectives: (1) Evaluation of the efficacy of vaccination against HPV 16, 18, 6 and 11 followed by local applications of imiquimod 5% cream compared to treatment with imiquimod alone for usual type VIN, (2) evaluation of the systemic and…

A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) in relapsed HCV-1 infected patients

The primary objective is: To evaluate the efficacy, safety and tolerability of NIM811 administered in combination with SOC in an interferon-relapser population of patients infected with chronic hepatitis C genotype-1.Secundary objectives are: * To…

The adenosine receptor; a new pharmacological tool in the treatment of sepsis.

Does antagonism of the adenosine receptor by caffeine lead to an increased LPS-induced inflammatory reaction and an increase in (subclinical) tissuedamage?Does the C34T-polymorphism of the enzyme AMP-deaminase lead to a decreased inflammatory…

A phase II, double blind randomized study to evaluate the efficacy of the therapeutic HIV-1 vaccine NYVAC-B versus placebo in chronic HIV-1 infected patients successfully treated with HAART (TheraVac-03)

Primary objective is to evaluate the HIV-1 specific immunity after two vaccinations with the HIV-1 specific recombinant vaccinia vaccine NYVAC-B, compared to placebo. Secondary objectives are the evaluate of the change in plasma HIV-1 RNA in…

A blinded, randomized, placebo-controlled trial in genotype 1 hepatitis C-infected subjects to evaluate the efficacy, safety, tolerability and pharmacokinetics of repeated doses of TMC435350, with or without peginterferon alpha-2a and ribavirin.

The primary objectives of this trial are the following:- to determine the dose dependency of the antiviral effect of TMC435350 during 1 week ofmonotherapy in treatment-naïve HCV-infected subjects;- to determine the dose dependency of the antiviral…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety ad Efficacy of GS-9620 for the Treatment of Virally-Suppressed Subjects with Chronic Hepatitis B

The primary objectives of this study are:• To evaluate the safety and tolerability of GS-9620 in subjects with chronic hepatitis B (CHB) infection currently being treated with oral antivirals (OAV)• To evaluate the efficacy of GS-9620 at Week 24…

Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculosis after successful intensive-phase treatment.

Primary endpoint: Evaluation of the safety of the novel anti-TB vaccine RUTI® (25*g FCMtb) in patients with MDR-TB favourably responding to second-line, standard MDRTB treatment through clinical, microbiological, and radiological response criteria.…