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NCT ID: NCT01077531 Terminated - Clinical trials for Arthritis, Rheumatoid

Safety, Pharmacodynamics and Pharmacokinetics of GSK2136525 Repeat Dose in Rheumatoid Arthritis

Start date: April 28, 2010
Phase: Phase 1
Study type: Interventional

The assessment of otelixizumab in rheumatoid arthritis subjects will provide safety, tolerability, pharmacodynamic and pharmacokinetic information which will enable the identification of appropriate safe and well-tolerated dosage regimens to be used in clinical efficacy studies. This study will consist of a screening phase, followed by a treatment period where four cohorts of subjects will receive 5 daily intravenous infusions of otelixizumab. The cumulative dose will increase in each successive cohort and infusion rates can be adjusted based on signs and symptoms of cytokine release syndrome and to ensure the specified maximum infusion rate is not exceeded. Serial blood samples will be obtained for clinical laboratory testing, determination of pharmacodynamic markers, serum otelixizumab PK parameters, exploratory biomarkers and immunogenicity. Safety and pharmacodynamic data from the previous cohort(s) will be evaluated prior to dosing subsequent cohorts to ensure safety. Adverse events, laboratory values, vital signs and ECG's will be monitored closely during this study. All subjects in the study will undergo long-term follow-up out to 48 months to monitor patient safety.

NCT ID: NCT01077518 Terminated - Clinical trials for Lymphoma, Follicular

Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

A+B
Start date: August 26, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

NCT ID: NCT01077154 Terminated - Breast Cancer Clinical Trials

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

Start date: June 2, 2010
Phase: Phase 3
Study type: Interventional

This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.

NCT ID: NCT01076751 Terminated - Prostatic Neoplasms Clinical Trials

Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients

PORTREAT
Start date: February 2010
Phase: N/A
Study type: Observational

Primary Objective: - Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression Secondary Objective: - Describe treatment patterns - Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others - Describe economic and patient-reported outcomes

NCT ID: NCT01074359 Terminated - Clinical trials for Neuromuscular Disease

Safety and Efficacy Study of A0001 in Patients With the A3243G Mitochondrial DNA Point Mutation

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This is a phase 2a, double-blind, placebo-controlled, single-center study. Twenty-one patients who qualify for the study will be randomly assigned to either active drug or placebo. The study will take place at Newcastle University. Patients will have a 66% chance of getting active drug. Patients will be required to take study treatment orally twice a day for 28 days. A baseline visit will occur within 21 days of screening visit. All patients will be followed for 1 week after completion of study or early withdrawal from the study.

NCT ID: NCT01072591 Terminated - Pain Clinical Trials

Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the Knee

Start date: February 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.

NCT ID: NCT01069861 Terminated - Clinical trials for Hypoxic Respiratory Failure

Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)

Start date: December 2010
Phase: Phase 2
Study type: Interventional

Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.

NCT ID: NCT01068184 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: February 2010
Phase: Phase 1
Study type: Interventional

AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the lungs in which the airways become inflamed and the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of airflow is poorly reversible and usually gets progressively worse over time. There is an urgent medical need for therapies that could slow disease progression by targeting the underlying mechanisms associated with the changes in the lungs in patients with COPD. AZD6553 acts by reducing the activity of a protease found to be involved in the disease process in COPD. AZD6553 is being developed as a novel oral treatment to control the symptoms and exacerbations of COPD, and reduce the progression and severity of the disease. The purpose of this research study is to determine how safe and well-tolerated AZD6553 is and how much AZD6553 enters blood circulation by collecting blood and urine samples during the study. We are also investigating what AZD6553 is broken down into, when given orally, how much of the drug is cleared from the body via the kidneys, and the effect of taking the drug after food. This will all be done by analysis of blood and urine samples taken at various point during the study.

NCT ID: NCT01064037 Terminated - Heart Failure Clinical Trials

A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

COMPOSE EARLY
Start date: April 2010
Phase: Phase 2
Study type: Interventional

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

NCT ID: NCT01061996 Terminated - Ulcerative Colitis Clinical Trials

Basiliximab Maintenance in Ulcerative Colitis

Start date: July 2007
Phase: Phase 2
Study type: Interventional

Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies. Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population