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NCT ID: NCT02303626 Completed - Clinical trials for Hereditary Angioedema

12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks

OPuS-2
Start date: November 2014
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.

NCT ID: NCT02303574 Completed - Clinical trials for Safety, Pharmacokinetics, Pharmacodynamics, Food Effect

Single + Multiple Ascending Dose and Food Effect Study of AZD7986 in Healthy Volunteers, PK, PD and Safety Study

Start date: December 3, 2014
Phase: Phase 1
Study type: Interventional

This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of AZD7986 in healthy volunteers

NCT ID: NCT02303509 Completed - Psoriasis Clinical Trials

Study to Assess Safety, Tolerability, Pharmacokinetic & Pharmacodynamic Effect of UCB5857 in Healthy & Psoriatic Subject

Start date: August 2013
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single doses of the drug. Part 2 of the study explores giving the drug every day for 14 days. The study uses healthy and psoriasis subjects.

NCT ID: NCT02303431 Completed - Clinical trials for Venous Thromboembolism

Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study

Start date: November 5, 2014
Phase: Phase 1
Study type: Interventional

This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.

NCT ID: NCT02303093 Completed - Clinical trials for Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG

Non-Interventional Study on the Tolerability and Efficacy of IVIG

GAM 10-06
Start date: August 1, 2011
Phase:
Study type: Observational

Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

NCT ID: NCT02302807 Completed - Bladder Cancer Clinical Trials

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]

Start date: January 13, 2015
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.

NCT ID: NCT02302664 Completed - Clinical trials for Achilles Tendon Rupture

PATH-2: Platelet Rich Plasma in Achilles Tendon Healing

PATH-2
Start date: July 2015
Phase: N/A
Study type: Interventional

Platelet Rich Plasma in Achilles Tendon Healing Does using a Platelet Rich Plasma (PRP) injection immediately before standard casting benefit patients aged 18 or over who are suitable for nonsurgical treatment of the Achilles tendon rupture (ATR)? This is a multicentre, blinded, randomised, placebo controlled trial with two sub studies: (1) blood sample analysis and (2) needle biopsy in 16 participants. ATR is the most common tendon injury and leads to months of incapacity. With an average work absence of 63108 days there are significant societal and National Health Service (NHS) costs. PRP potential benefit is to improve recovery and return to normal activities earlier, and reduce the NHS and societal impact. The investigators will investigate the efficacy of PRP using disease specific and patient important outcomes to improve the evidence for this treatment of ATR. A minimum of 15 United Kingdom (UK) NHS hospitals will be included to recruit 214 participants. Patients will be identified in the orthopaedic outpatient clinic, usually following an emergency hospital attendance for ATR. After checking eligibility and the informed consent process, baseline data is collected and participants randomised to either 'PRP injection' or 'Imitation (placebo) injection'. A participant's own blood sample is taken and prepared according to allocation. The injection is delivered by a trained surgeon in clinic who will be aware of allocation while the participant remains blind. Participants complete a pain diary and have four study assessments at 4,7,13 and 24 weeks, carried out by a member of the research team blind to allocation. Assessments take place over the telephone or during a hospital outpatient visit. The 24 week hospital visit includes an exercise test of ankle function. All assessments include collection of patient reported responses to pre-set questions. The results may be applicable to the many other tendon and ligament injuries. The National Institute for Health Research (NIHR)/Medical Research Council (MRC) Efficacy and Mechanism Evaluation Programme provides funding and University of Oxford is Sponsor.

NCT ID: NCT02302404 Completed - Clinical trials for Inflammatory Bowel Diseases

A Safety and Tolerability Study of GSK2982772, in Single (in Both Fed and Fasted States) and Repeat Oral Doses in Healthy Male Subjects

Start date: January 6, 2015
Phase: Phase 1
Study type: Interventional

This study is the first administration of GSK2982772 in humans. The study will evaluate the safety, tolerability, pharmacokinetics (PK), and exploratory pharmacodynamics (PD) of single and repeat oral doses of up to 14 days with GSK2982772 in healthy male subjects. This study is planned to include approximately 52 subjects and will consist of 2 parts: Part A - single ascending dose, randomized, placebo controlled, 4 way crossover. In addition to the crossover treatment periods, up to 8 subjects in cohort 2 will participate in an additional treatment period and receive GSK2982772 with a high-fat meal. Part B - repeat dose, randomized, placebo controlled, sequential-group. In both cohorts of Part A (Cohorts 1 and 2), subjects will be randomized equally (1:1:1:1) to one of 4 treatment sequences. Within each period, allocation of active to placebo treatment will be 3:1. In all cohorts in Part B (Cohorts 3, 4 and 5) subjects will be randomized to GSK2982772 or placebo in a 3:1 ratio. If required, subjects in the additional cohorts in Part A (Cohort 6) and Part B (Cohort 7) will be randomized to GSK2982772 or placebo in a 1:1:1:1 and 3:1 ratio, respectively. The study duration, including screening and follow-up, is not expected to exceed 105 days for any subject in the study.

NCT ID: NCT02302014 Completed - Clinical trials for Acute Coronary Syndrome

Palliative Care for Patients With Advanced Heart Disease

FLAME
Start date: August 2013
Phase: Phase 2
Study type: Interventional

Patients admitted as an unscheduled hospital admission with either a acute heart failure syndrome (ACF) or acute coronary syndrome (ACS) will be eligible if their 6-12 month mortality risk is estimated to be 20% or greater at the time of discharge. Mortality risk is estimated using GRACE (for ACS) or EFFECT (for AHF) scores. Patients are randomly allocated to receive a holistic care intervention based around the creation of a detailed Future (anticipatory) Care Plan which is agreed with the patient and their family and which is shared with the Family Doctor and Emergency Services including ambulance teams. Primary endpoint is quality of life assessed by questionnaire.

NCT ID: NCT02301624 Completed - Clinical trials for Refractory Generalized Myasthenia Gravis

Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis

Start date: November 12, 2014
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).