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A single-center, open-label, fixed-sequence Phase 1 trial to evaluate the effect of multiple
doses of pritelivir on the pharmacokinetics of substrates for CYP2C9, CYP2B6, CYP3A4
and OATP2B1

In this study, we will investigate how quickly and to what extent the investigational medicinal product pritelivir is absorbed, transported, and eliminated from the body (this is called pharmacokinetics). In addition, we will evaluate a possible…

Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial (COVID-Compromise Study).

There have been reports of a more serious course of COVID-19 infections in patients with a reduced immune system, such as patients with congenital immune disorders, (haematological) malignancies or patients taking medications that suppress the…

A single-center, double-blind, randomized, phase I/II dose escalating study to assess the safety, tolerability and immunogenicity of three doses of the therapeutic synthetic long peptide (SLP) vaccine (ISA104) in patients with chronic hepatitis B (cHBV).

This study has been transitioned to CTIS with ID 2024-518355-36-00 check the CTIS register for the current data. Primary objective:- To determine the safety and optimal dose of three doses of a novel therapeutic vaccine (ISA104) consisting of 12…

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study To Assess The Safety, Tolerability, Pharmacokinetics Of Two Monoclonal Antibodies In Healthy Volunteers

In this study we will investigate how safe the experimental compounds AER001 and AER002 are and how well they are tolerated when they are used in healthy subjects.We also investigate how quickly and to what extent AER002 (as a single dose) and…

A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19

Primary Objective:To evaluate recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo.Secondary Objectives:a. To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19, using a…

A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group,
group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for the
treatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.

The overall objective of this trial is to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalized patients with mild to moderate COVID-19 symptoms and to identify a potentially efficacious and safe dose regimen from Phase…

Virology markers after participation EYP001-103 study part B

The aim is to check on current virology values (viral load (HBV DNA) and quantified HBsAg, HBcrAg, HBV RNA) to clarify if a complete return to baseline has occurred or if decreased values are still observable in patients that participated in part B…

Early effects of Vaccine Immunisation

Primary objective: To obtain insight into signature of immune responses triggered by a bivalent- or nonavalent HPV vaccination (three-dose schedule). Secondary objectives: To determine the most informative time-points to study different innate and…

The influence of young child formula containing short-chain galactooligosaccharides, long-chain fructooligosaccharides and n-3 long-chain polyunsaturated fatty acids on recurrent upper respiratory tract infections in children: a randomised, controlled trial.

To evaluate whether YCF with added scGOS/lcFOS and n-3 LCPFUAs can decrease the number of upper respiratory tract infections compared to cow*s milk in children aged 12-36 months with recurrent upper respiratory tract infections.

B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping

Primary objective:To assess the effect of 12 weeks of GSK3228836 on serum hepatitis B virus surface antigen (HBsAg) levels in participants with CHBSecondaryEfficacy: To assess sustainability of serum HBsAg loss by GSK3228836 for up to 24 weeks off-…

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED,
PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND
SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F
SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING
PREGNANCY
Short title: A Phase 3 Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

to assess the efficacy, safety, and immunogenicity of bivalent RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women.

A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease

To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Mortality.

A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734*) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment

The purpose of this study is to provide remdesivir (RDV) to participants with moderate COVID-19. The primary objective of this study is as follows: To evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with…

Neutrophil extracellular trap induced changes in (RSV-infected) pediatric human airway epithelial (HAE) cultures.

1) to determine NETs-induced changes in ex vivo (RSV-infected) pediatric HAE (e.g. mucus hypersecretion and cell death) and 2) to explore pharmacological inhibition of NETs in this context.

Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial.

What is the (cost-)effectiveness of salbutamol inhalations (4x200*g for 7 days) versus placebo in children aged 6-24 months presenting to their primary care physician with wheezing?

The TRISTARDS trial - ThRombolysIS Therapy for ARDS
A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19.

Main objective is to evaluate the efficacy and safety of two (Part 1) different dosing regimen and of one dosing regimen (Part 2) of intravenous alteplase given for up to 5 days on top of standard of care (SOC) compared with SOC alone in ARDS…

Prospective cohort study of respiratory viral infections and mucosal immune responses in community-dwelling adults >= 65 years old

The aim of the proposed study is to describe in older adults the incidence of respiratory viral infections and to gain better insight into the nasal mucosa and mucosal and systemic immune responses in older adults in the absence and presence of a…

Relative bioavailability study to investigate a potential interaction between dolutegravir (DTG) and tenofovir alafenamide fumarate/emtricitabine (F/TAF) administered as paediatric tablet formulations.

Primary objectives:- To assess the relative bioavailability of TAF and TFV after a single-dose FTC/TAF 3x60/7.5 mg DT (reference TAF) compared to TAF and TFV after a single-dose FTC/TAF 3x 60/7.5mg DT in combination with a single dose of DTG 30mg as…

The influence of having bariatric surgery on the pharmacokinetics, safety and efficacy of the novel non-nucleoside reverse transcriptase inhibitor doravirine (LABRADOR)

Primary objective: • To assess the pharmacokinetics of DOR in patients prior to and after BSSecondary objectives: • To assess the safety of DOR in patients prior to and after undergoing BS• To assess the viral response to DOR in patients prior to…

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 in Adults Hospitalized with COVID-19

To evaluate the safety and tolerability of single ascending doses of ABBV-47D11 in subjects hospitalized with COVID-19.