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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 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 two-period microdosing study to determine the single-dose pharmacokinetics of ITMN-8187 after intravenous and oral administration in healthy subjects.

Primary:- to determine the pharmacokinetics (PK) of parent drug and total radioactivity after administration of the studydrugSecondary:- to determine the absolute bioavailability of ITMN-8187 after oral administration- to investigate the safety and…

The role of paroxetine in patients taking telaprevir-based HCV therapy: lack of a drug-drug interaction? (ROLEX)

Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…

Pharmacokinetic and safety pilotstudy of RAltegravir and atazanavir in a once DAily dose regimen in HIV-1 in-fected patients (PRADA)

Primary: To compare the pharmacokinetics of raltegravir 400 mg twice daily vs. ralte-gravir 800 mg once daily (QD) by intrasubject comparison. Secondary: To determine the efficacy of an antiretroviral regimen consisting of raltegravir 800mg QD,…

A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C who Achieve an Extended Rapid Viral Response (eRVR) While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

Primary:To estimate the difference in SVR rates between T12/PR24 and T12/PR48 treatment regimens in subjects who achieve eRVR.Secondary:To evaluate the safety of telaprevir in combination with Peg-IFN-alfa-2a and RBV in treatment-naïve subjects with…

How well is the efficacy of hepatitis A vaccination in elderly people?

React elderly >60 years of age just as good and quickly to hepatitis A vaccination as younger travellers?

CD8 T-cell expansions in HIV patients, treated with HAART, who have long-term suppression of HIV-RNA

To determine the nature of these expanded CD8 T-cell subsets, by performing apoptosis resistance assays and phenotypic analysis of markers that are primarily found on so-called exhausted cells.

Infection serology in persons with putative exposure to flaviviruses through imported Aedes albopictus mosquitoes in the Netherlands

To make a risk estimation of the risk for public health, research is needed about:1. How many Ae. Albopictus are being introduced in the Nederlands?2. Does Ae. albopictus settle permanently in the Nederlands? If yes, where?3. Do the imported…

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 Objectives:The 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 multiple dosing study to demonstrate the safety, tolerability, pharmacokinetics and efficacy potential of intravenously administered ANXV (a recombinant human Annexin A5) in patients with confirmed moderate to severe COVID-19; The CO-ANNEXIN Study.

Primary Objective:To evaluate the efficacy potential, safety and tolerability of intravenously administered ANXV, in ascending doses, and two different dosing regimens, in patients with confirmed moderate to severe COVID-19.Secondary Objectives:To…

A PHASE II, RANDOMISED, ADAPTIVE, OPEN-LABEL
PLATFORM TRIAL TO EVALUATE EFFICACY AND
SAFETY OF MULTIPLE COMBINATION THERAPIES IN
PARTICIPANTS WITH CHRONIC HEPATITIS B

Primary* To estimate the effect of NME combination therapies on inducing a functional cure over the control arm.Secondary * To characterize the efficacy profile of NME combination therapies.* To characterize the PD profile of NME combination…

Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)

This study has been transitioned to CTIS with ID 2024-515487-31-00 check the CTIS register for the current data. The primary objective of this study is to describe the pharmacokinetics of antiretroviral agents, for which no or limited available…

A PHASE I, SPONSOR-OPEN, INVESTIGATORBLINDED,SUBJECT-BLINDED, MULTI-CENTER,
PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS
AND PHARMACODYNAMICS OF ORAL ADMINISTRATION OF RO7020531: (1). SINGLE
AND MULTIPLE ASCENDING DOSES IN HEALTHY MALE AND FEMALE SUBJECTS; (2). 6-WEEK
TREATMENT OF VIROLOGICALLY SUPPRESSED PATIENTS WITH CHRONIC HEPATITIS B VIRUS
INFECTION

OBJECTIVESPrimary ObjectivesThe primary objective is:* To assess the safety and tolerability of 6 weeks of treatment with RO7020531 administered orally to virologically suppressed chronic hepatitis B (CHB) patients.Secondary ObjectivesThe secondary…

Immunogenicity of HPV-vaccination in a reduced-dose schedule

- To study the kinetics of the vaccine-induced antibody response against HPV16/18 after a two-dose schedule by measuring these antibody responses at approximately 7, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 months following the first dose of HPV-…

COVID-19 in patients with chronic inflammatory diseases: a prospective cohort study

The primary objective will focus on both the difference in incidence and disease severity of COVID-19 between patients with a chronic inflammatory disease and the control group.

COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older.

Objectives for the Randomized Observe-Blinded Phase:Primary Objectives:Primary Efficacy Objective• To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

Primary ObjectiveThe primary objective is to evaluate superiority of pimodivir in combination with SOC treatment compared to placebo in combination with SOC treatment on Day 6, with respect to the clinical outcome on the hospital recovery scale.

The effect of medical grade honey (L-Mesitran) for cervical intraepithelial neoplasia-II

The primary aim of this study is to investigate the effect of honey on the clearance of the hr-HPV virus in patients with CIN II.Secondary, the effect of honey on the normalization of CIN lesions, the role of the vaginal microbiome, the local immune…

COBRA re-KAI study: COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after re-vaccination of a kaleidoscopic group of hematological patients: what*s the impact?

To answer the following questions: 1. Who are the patients that need to be revaccinated?2. How many vaccinations are needed to restore SARS-CoV-2 immunity?3. Can the number of vaccinations needed to restore SARS-CoV-2 immunity be predicted?To answer…