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NCT ID: NCT01387854 Completed - MPS VI Clinical Trials

Observational Study of Patients With Mucopolysaccharidosis (MPS) VI Who Previously Participated in ASB-00-02

Start date: June 2011
Phase: N/A
Study type: Observational

There is limited information on the long-term effects of treating patients with MPS VI with Naglazyme® and limited data on the natural history of treated and untreated MPS VI patients. The Re-survey Study ASB-00-03 will assist in understanding the effects of long-term Naglazyme treatment and the natural history of the MPS VI patient population.

NCT ID: NCT01387282 Completed - Clinical trials for Non-Small Cell Lung Cancer

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)

Start date: July 2011
Phase: Phase 3
Study type: Interventional

The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

NCT ID: NCT01387217 Completed - Multiple Sclerosis Clinical Trials

GSK2018682 FTIH in Healthy Volunteers

P1A114070
Start date: May 21, 2010
Phase: Phase 1
Study type: Interventional

This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.

NCT ID: NCT01386905 Completed - Obesity Clinical Trials

A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects

Start date: June 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the feasibility of the TransPyloric Shuttle™ (TPS™) when used to treat obesity.

NCT ID: NCT01386658 Completed - Clinical trials for Hereditary Angioedema (HAE)

A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema

Start date: January 27, 2012
Phase: Phase 3
Study type: Interventional

HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.

NCT ID: NCT01385657 Completed - Atopic Dermatitis Clinical Trials

Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis

Start date: July 31, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT01385644 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Potential Role of Mesenchymal Stem Cells in the Treatment of Idiopathic Pulmonary Fibrosis

MSC in IPF
Start date: October 2010
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to establish the feasibility and safety of infusions of placental Mesenchymal Stem Cells (MSC) from related or unrelated HLA identical or HLA mismatched donors in the treatment of Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives are to document changes in lung function, 6 minute walk distance (6MWD), gas exchange and radiological appearance following infusion of MSC over a six month evaluation period.

NCT ID: NCT01384682 Completed - HIV Clinical Trials

Maraviroc Switch Collaborative Study

MARCH
Start date: August 2011
Phase: Phase 4
Study type: Interventional

MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will be randomized (1:2:2) to one of three treatment groups: to continue their current treatment regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic assessment of tropism cannot be used to determine tropism, instead we will employ the genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim of this study is to investigate whether switching to maraviroc, in combination with either RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI with PI/r. The other aim is to see if switching to these combinations with maraviroc will improve some of the side effects that can be seen when people take combination therapy including RTI and PI/r. The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200 copies/mL) patients with no history of prior virological failure, a switch to either MVC dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.

NCT ID: NCT01383421 Completed - Clinical trials for Rheumatoid Arthritis

Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)

PASSION
Start date: September 2011
Phase: N/A
Study type: Observational

Post-marketing observational study to determine the effectiveness and patient satisfaction with adalimumab treatment in patients with Rheumatoid Arthritis in relation to utilization of a Patient Support Program (PSP).

NCT ID: NCT01383096 Completed - Healthy Volunteers Clinical Trials

Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers

Start date: April 2012
Phase: Phase 1
Study type: Interventional

This study is designed to assess prototype formulations compared to the aqueous dispersion of Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that observed when given after food. This will improve the utility of OZ439 in the field as well as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very important for an antimalarial drug product destined for use in developing counties.