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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 (…

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…

A pilot study on the efficacy and pharmacokinetics of a switch from nevirapine with emtricitabine, tenofovir or lamivudine, tenofovir or lamivudine, zidovudine to rilpivirine with emtricitabine, tenofovir in virologically suppressed HIV-1 infected patients.

Primary objective:To evaluate the efficacy of a RPV based HAART in patients that switch from NVP with FTC, TDF or lamivudine (3TC), TDF or 3TC, zidovudine (ZDV) to RPV/FTC/TDF.Secondary objectives:To measure the impact (strength and duration) of NVP…

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…

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…

Serum antibody response to influenza A in children with Down syndrome

Measuring specific antibody titers against influenza A (subtype H1N1 and / or seasonal vaccine) in DS children. DS anti-influenza antibody titers will be compared with controls available from the same laboratory.

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

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).

Phase I, open-label, 3-way crossover trial in healthy male subjects to
evaluate the pharmacokinetics of TMC114 and TMC41629 after a
single oral dose of 2 controlled-release coformulations as compared to
an immediate-release coformulation of TMC114/TMC41629

This is a scientific research with the aim to investigate the bioavailability of a combination of the drugs TMC114 and TMC41629 . The three dosage forms, each only once ingested. In addition, even in this study the safety of the use and possible…

A Phase I, open-label trial to investigate the pharmacokinetic interaction between TMC125 and two antifungal agents (fluconazole and voriconazole), all at steady-state in healthy subjects.

The objectives are:1. the effect of steady state concentrations of voriconazole and fluconazole on the steady-state pharmacokinetics of TMC125,2. the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of…

A single dose study to evaluate the microdose pharmacokinetics of candidate HIV integrase
strand transfer inhibitors in healthy subjects

The purpose of the study is to investigate to what extent L-1, L-2 and L-3 are tolerated when administered as micro-dose.It will also be investigated how quickly and to what extent L-1, L-2 and L-3 are absorbed and eliminated from the body (this is…

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.

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Coadministration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

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, Single-arm, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH).

Primary Objectives:• To determine the safety of ELA026 administered IV and SC to participants with sHLH.• To identify the RP3D and schedule for ELA026.Secondary Objectives:• To characterize the pharmacokinetic (PK) profile of ELA026 administered IV…

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…

PK/PD of corticosteroids in graft-versus-host disease after hematopoietic cell transplantation in children

To assess the PK/PD relationship of prednisolone as either prophylaxis or therapy of GVHD in children after HCT.

Long-term outcomes in immunologically low-risk kidney transplant recipients using tacrolimus.
Extension study of: Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study.

This study has been transitioned to CTIS with ID 2024-513394-42-01 check the CTIS register for the current data. To assess long-term outcomes in low-immunological risk renal transplant patients beyond one year after transplantation using tacrolimus…

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Con

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

A Phase I, open label, randomized, crossover trial in healthy subjects to investigate the pharmacokinetic interaction between didanosine and TMC114, coadministered with low-dose ritonavir, at steady-state.

The primary objectives are:* to determine the effect of steady-state concentrations of TMC114 coadministered with a lowdose of ritonavir on the steady-state pharmacokinetics of ddI,* to determine the effect of steady-state concentrations of ddI on…