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NCT ID: NCT01769001 Completed - Fabry Disease Clinical Trials

An Extension of a Phase 1/2, Open Label, Dose Ranging Study of PRX-102 in Adult Fabry Patients

Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Patients will be enrolled into one of three PRX-102 dosing groups (0.2 mg/kg, 1.0 mg/kg, 2.0 mg/kg), to receive the same dose they had received in Phase 1/2 study PB-102-F01, and will continue to receive PRX-102 as an intravenous infusion every 2 weeks for 38 weeks.

NCT ID: NCT01768624 Completed - Clinical trials for Chronic Kidney Disease

PINOT Follow-up Study in End-stage Kidney Disease

Start date: October 2012
Phase: N/A
Study type: Observational

The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that: (i)Made the transition to home dialysis, after an initial start on center-based dialysis. (ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed plans for conservative care. The hypotheses to be tested in the PINOT follow-up study are: 1. 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not commence home dialysis within 3 years, and instead remain on centre-based haemodialysis; and, 2. less than 15% of stage 5 chronic kidney disease patients who plan for conservative care commence dialysis within 3 years.

NCT ID: NCT01768572 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Start date: March 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.

NCT ID: NCT01768559 Completed - Type 2 Diabetes Clinical Trials

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

GetGoal Duo-2
Start date: January 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: - To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin. Secondary Objectives: - To compare the treatments/regimens on: - The percentage of patients reaching the target of HbA1c <7% or ≤6.5% - Body weight - Self-Monitored Glucose profiles - Fasting Plasma Glucose (FPG) - Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients) - Daily doses of insulins - Safety and tolerability

NCT ID: NCT01767701 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis

INSPIRE
Start date: April 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether raltegravir is effective in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium- enhanced MRI.

NCT ID: NCT01767623 Completed - Neoplasms Clinical Trials

A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants

Start date: August 20, 2013
Phase: Phase 1
Study type: Interventional

This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer. Participants will receive vemurafenib 960 milligrams (mg) (normal hepatic function) or 720 mg (severe hepatic impairment) orally twice daily (BID) on Days 1 to 20 (morning dose) and from Day 27 onward until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01767558 Completed - Atrial Fibrillation Clinical Trials

PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)

Start date: January 2013
Phase: N/A
Study type: Interventional

PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

NCT ID: NCT01767519 Completed - Clinical trials for Urinary Incontinence

A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

Start date: March 1, 2013
Phase: Phase 3
Study type: Interventional

A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.

NCT ID: NCT01767467 Completed - Herpes Zoster Clinical Trials

Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

Start date: March 1, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

NCT ID: NCT01767155 Completed - Endometrial Cancer Clinical Trials

Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer

ZoptEC
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.