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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 (…

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…

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, 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.

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…

An open-label, non-randomized, within-patient dose-finding study followed by a randomized, subject, investigator and sponsor-blinded placebo controlled study to assess the efficacy and safety of CDZ173 in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/
p110*-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

This trial is, along with establishment of the safety, tolerability and pharmacokinetics and -dynamics of CDZ173 in the target population, designed to select the optimal dose to normalize the function of the PI3K protein in patients with APDS/PASLI…

Switching to Tenofovir Alafenamide Fumarate or ABACavir in patients with Tenofovir Disoproxil Fumarate associated eGFR decline. A randomized clinical trial.

To study the renal safety when HIV patients with TDF related renal toxicity switch to TAF compared to the current practice of switching to ABC.