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A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (miravirsen) Administered to Treatment-Naïve Subjects with Chronic Hepatitis C (CHC) Infection

Main objectiveTo determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with CHC.Secondary objectivesTo assess the pharmacokinetics (PK) of multiple dosing of miravirsen administered subcutaneously to subjects…

Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911.

Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…

A randomised controlled trial on the effectiveness of post-exposure prophylaxis (PEP) with oseltamivir in preventing influenza transmission in nursing home units

If proven (cost)effective, without inducing antivral resistance, oseltamivir could have considerable benefits in this setting, although constraints relating to implementation need to be addressed as well. If not (cost)effective if this fragile…

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults.

To assess non-inferiority of a regimen containing ritonavir-boosted elvitegravir versusraltegravir, each administered with a background regimen in HIV-1 infected,antiretroviral treatment-experienced adult subjects as determined by the proportion…

Clinical and immunological effects of imiquimod and HPV-vaccination compared to imiquimod alone in female patients with Usual type VIN: proof of principle.

Primary objectives: (1) Evaluation of the efficacy of vaccination against HPV 16, 18, 6 and 11 followed by local applications of imiquimod 5% cream compared to treatment with imiquimod alone for usual type VIN, (2) evaluation of the systemic and…

The effects of preventive versus on demand nutritional advice and support on the nutritional status of patients during antiviral therapy for hepatitis C

Primary:Assessment of the effect of preventive versus on demand nutritional advice and a nutritional supplement (a daily energy- and protein-rich evening snack) on weight loss of patients receiving standard antiviral therapy with PEG-interferon in…

A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) in relapsed HCV-1 infected patients

The primary objective is: To evaluate the efficacy, safety and tolerability of NIM811 administered in combination with SOC in an interferon-relapser population of patients infected with chronic hepatitis C genotype-1.Secundary objectives are: * To…

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…

A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment.

The primary objective is to demonstrate the superior efficacy of telaprevir in combination withPeg-IFN alfa-2a and RBV compared to standard treatment in subjects with chronic HCVgenotype 1 infection who failed prior treatment with Peg-IFN plus RBV.…

Phase I, double blind, randomized, placebo-controlled trial in healthy subjects to examine the safety, tolerability and pharmacokinetics of increasing oral doses of TMC435350 after single and repeated dosing, followed by an open label repeated dosing session in 6 HCV-genotype 1 infected patients (non placebo-controlled).

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A Phase 2 Study of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys??), and Ribavirin (Copegus??) in Subjects with Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response with a Prior Course of Interferon Based Therapy

To compare to control (Group A) (peginterferon alfa-2a [Peg IFN-*-2a] and ribavirin [RBV] for 48 weeks) the proportion of subjects who achieve sustained viral response (SVR, undetectable HCV RNA 24 weeks after completion of treatment) when given…

Monochloroacetic acid versus cryotherapy or combination therapy in the treatment of warts: A Randomised Clinical Trial (WARTS-2)

To assess the efficacy of treatment with monochloroacetic compared to treatment with cryotherapy regarding patients with handwarts and compared to combination therapy (salicylic acid and cryotherapy) regarding patients with plantar warts.WARTS-1 has…

Prednisolone Rhinosinusitis Efficacy Trial (PRET) study

To assess the effects of a 7-day course of 30 mg prednisolone daily in addition to usual care (symptomatic) treatment in adults with RS.

A phase IV, open label, randomized, multicountry study to evaluate immunogenicity and safety of GSK Biologicals' seasonal (2010-2011) influenza vaccine Fluarix in children previously vaccinated with GSK Biologicals' H1N1 vaccine (Pandemrix)

The objective of this study is to evaluate the immune respons against the H1N1 strain following vaccination with the first dose of trivalent inactivated influenza virus vaccine (Fluarix) in subjects previously vaccinated with 2 doses of H1N1…

A single ascending dose study to assess the safety, tolerability and pharmacokinetics of RO5428029 in healthy male subjects

To evaluate the safety, tolerability and pharmacokinetics of RO5428029 in healthy male subjects.

A randomized open-label prospective trial for comparing combination therapy Peg-Interferon alfa-2a (PEGASYS®) and Adefovir dipivoxil (Hepsera®) and combination therapy Peg-Interferon alfa-2a (PEGASYS®) and Tenofovir disoproxil fumarate (Viread®) versus no treatment in HBeAg negative chronic hepatitis B patients with low viral load*

The aim of this study is to investigate what proportion of HBeAg negative, inactive carriers of the hepatitis B virus with low (< 20,000 IU/mL) load will lose HBsAg when treated with nucleot(s)ide analogue/Peg-IFN combination therapy.

A phase III, observer-blind, multicountry, multicentre study to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals' GSK2186877A influenza vaccine administered to adults aged 66 years and older compared to Fluarix* administered to adults aged 19-43 years and 66 years and older, who previously participated in the 111737 study.

Primary objective is to assess the safety and reactogenicity during the entire study period in subjects aged 66 years (previously enrolled in the FLU NG-036 EXT 025 Y1 study) vaccinated with the FLU NG vaccine or with Fluarix*, and in subjects aged…

A placebo-controlled, double-blind, randomised, multiple dose, dose escalating study in healthy subjects to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649

Main objective• To determine the safety and tolerability of multiple dosing of SPC3649Secondary objectives• To assess the pharmacokinetics (PK) of multiple dosing of SPC3649 administered by i.v. and s.c. route in healthy volunteers• To evaluate the…

A randomized, open-label, controlled, multi-center two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 µg with peg alpha-2a monotherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive CHB.

The primary objective of this study is to demonstrate the superior antiviral efficacy of the combination of peginterferon alpha-2a plus telbivudine vs peginterferon alpha-2a monotherapy as demonstrated by HBV DNA non-detectability using the COBAS…

A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C (CHC) Infected With Genotype 1

The primary objective of this study is to evaluate the efficacy of SCH 503034800 mg TID PO in combination with PegIntron 1.5 *g/kg QW SC plus ribavirin (800 - 1400 mg/day) in previously untreated adult chronic hepatitis C (CHC) subjects infected…