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Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients

MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…

Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003.

Primary objective: To evaluate the long-term safety of IgPro20.Secondary objectives: * To evaluate the long-term safety of IgPro20 by dose. * To evaluate the efficacy of IgPro20.Exploratory objectives:* To evaluate health-related quality of life (…

Randomized, multicenter, double-blind, placebo-controlled, parallel group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

The primary objective of the study is to determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placeboSecondary objectives:* To investigate the efficacy of…

Efficacy of 12 week boceprevir in addition to standard of care therapy consisting of peginterferon-alpha-2b and ribavirin for the treatment of acute HCV genotype 1 in HIV co-infected patients. A proof of concept feasibility clinical trial.

Document the efficacy and tolerability of 12 weeks of Boceprevir (Victrelis®) therapy in addition to standard of care (SOC) therapy consisting of weekly weight based peginterferon alfa-2b (Pegintron®) SC and ribavirin PO BID, for the treatment of…

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…

An open-label randomised two-year trial comparing two first-line regimens in HIV-infected antiretroviral naïve subjects:
darunavir/r + tenofovir/emtricitabine vs. darunavir/r + raltegravir

Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…

An open-label trial with TMC278 25 mg q.d. in combination with a
background regimen containing 2 nucleoside/nucleotide reverse
transcriptase inhibitors in HIV-1 infected subjects, who participated in
TMC278 clinical trials.

Primary ObjectiveThe primary objective of the trial is to provide continued access to TMC278 for subjects who were randomized andtreated with TMC278 in the Phase IIb (e.g., TMC278-C204 [C204]) or Phase III trials (e.g., TMC278-TiDP6-C209[ECHO] and…

A multicentre, prospective, randomized open-label pilot study to assess the feasibility and preliminary efficacy of interferon gamma in combination with Anidulafungin for the treatment of candidemia

To evaluate the preliminary efficacy and feasibility of interferon gamma as adjunctive treatment in combination with the standard regimen, for the treatment of patients with candidemia using the following parametersSecondary objective: to evaluate…

Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml

The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…

A Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin with Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects

Primary: To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy(i.e. amantadine and ribavirin co-administered with oseltamivir) compared to oseltamivirmonotherapy in immunocompromised subjects diagnosed with Influenza…

The role of TSH in the human immune system, a randomized, controlled, trial

The main objective of this study is to determine the role of TSH in the generation of new T cells by thymopoiesis

A randomized, multicenter study to assess the efficacy on disease activity on enteric-coated mycophenolate sodium (EC-MPS, myfortic) versus continuation of azathioprine in patients with systemic lupus erythematosus on azathioprine maintenance therapy.

To assess, in patients with systemic lupus erythematosus, the effect on disease activity of a regimen with myfortic® versus continuation of azathioprine.

Glivec (imatinib mesylate) in systemic sclerosis, a pilot study

To investigate the efficacy (and the toxicity) of Glivec in systemic sclerosis by examining clinical outcomes (clinical and laboratory findings).

Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD).

Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…

A Phase III, randomized, double-blind study of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects.

The primary objective of the trial is to demonstrate non-inferiority of treatment with TMC278 when administered as 75 mg q.d. compared to the control group (EFV) in regard to the proportion of virologic responders (plasma viral load < 50 HIV-…

A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

Main objective:To evaluate the non-inferiority of switching to the FTC/RPV/TAF FDC as compared to continuing FTC/RPV/TDF FDC in virologically suppressed HIV-1 infected subjects as determined by maintaining HIV-1 RNA < 50 copies/mL at Week 48…

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…

Effects of nicotinamide riboside (vitamin B3) in patients with Ataxia Telangiectasia

The purpose of this research is to investigate whether treatment with nicotinamide riboside (vitamine B3) has a positive effect on the disease course of patients with ataxia telangiectasia.

PHASE I/II CLINICAL TRIAL OF AUTOLOGOUS HEMATOPOIETIC STEM CELL GENE THERAPY FOR RAG1-DEFICIENT SEVERE COMBINED IMMUNODEFICIENCY

This study has been transitioned to CTIS with ID 2023-510204-50-00 check the CTIS register for the current data. Primary: The main objectives of the study are to demonstrate feasibility and safety of gene corrected autologous CD34+-selected…

An open-label, 8-week, proof of concept trial on thymosin-α1 (thymalfasin) in the treatment of primary antibody deficiency (PAD) associated mood disorders (TIDAM).

Based on the effects of Tα1 on immune cell function, the known disturbances in T lymphocyte numbers and subsets in patients with CVID and the increased prevalence of mood disorders in these patients the following research questions have been…