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NCT ID: NCT02966834 Completed - Cholestasis Clinical Trials

Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis

Start date: January 11, 2017
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will receive either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Participants on GSK2330672 will also receive placebo tablets to maintain blinding. The study has a prospectively defined adaptive design that will utilize interim data to further inform and potentially optimize the doses under investigation. Hence, additional dose regimen may be added during study. The total duration of a participant in the study will be up to 45 days of screening and 24 weeks of study including follow-up.

NCT ID: NCT02966353 Completed - Clinical trials for Primary Myelofibrosis

Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

REALISE
Start date: March 31, 2017
Phase: Phase 2
Study type: Interventional

This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction

NCT ID: NCT02965885 Completed - Clinical trials for Advanced Solid Tumors

A Study of TAS-116 in Patients With Solid Tumors

Start date: July 10, 2017
Phase: Phase 1
Study type: Interventional

A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase. Three dosing regimens of TAS-116, once daily (QD), every other day (QOD) and 5 days on/2 days off regimens in 21-day cycles, are being evaluated. This phase I study is also planned to enroll patients with advanced solid tumors in UK to confirm the MTD, safety, tolerability, and pharmacokinetics of TAS-116 in a Western patient population in the dose expansion phase. In addition, patients with HER2+ MBC, NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further evaluated for safety, tolerability, and efficacy in 3 separate cohorts at recommended dose of TAS-116 on the 5 days on/2 days off regimen.

NCT ID: NCT02965573 Completed - Myasthenia Gravis Clinical Trials

A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

Start date: December 30, 2016
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.

NCT ID: NCT02965287 Completed - Fetal Anomaly Clinical Trials

Validation of a Test for Fetal Malformations

Start date: September 2016
Phase:
Study type: Observational

The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and subsequent mathematical modeling analysis of the data by means of multivariate mathematical models specifically developed for this purpose. The study aims at determining the performance parameters (specificity, sensibility, positive predictive value (PPN), negative predictive value (NPV), etc.) of the test and its applicability. To do this, the investigators will use the serum samples of the patients enrolled in New Zealand in the SCOPE Study (www.scopestudy.net), an international study conducted between years 2004-2008.

NCT ID: NCT02964273 Completed - Clinical trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Start date: September 23, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and efficacy of tolvaptan in the same participant population.

NCT ID: NCT02964208 Completed - Stroke Clinical Trials

AMPLATZERā„¢ LAA Occluder Post Approval Study (PAS)

Start date: December 8, 2016
Phase:
Study type: Observational

The aim of this multicenter, non-randomized observational post-approval is to compile real world outcome data on the use of an AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF). The AMPLATZER LAA Occluders is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA.

NCT ID: NCT02963922 Completed - Obesity Clinical Trials

Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin

SCALEā„¢ Insulin
Start date: February 6, 2017
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to investigate effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin.

NCT ID: NCT02963649 Completed - Clinical trials for Peripheral Arterial Disease

IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Start date: March 2, 2017
Phase: N/A
Study type: Interventional

To assess the safety and efficacy of the paclitaxel drug-eluting balloon IN.PACT 014 versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.

NCT ID: NCT02963493 Completed - Multiple Myeloma Clinical Trials

A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

HORIZON
Start date: December 28, 2016
Phase: Phase 2
Study type: Interventional

This study will evaluate melflufen in combination with dexamethasone in adult patients with relapsed or refractory multiple myeloma in whose disease is refractory to pomalidomide and/or an anti-CD38 monoclonal antibody. All patients in the study will be treated with melflufen on Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.