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NCT ID: NCT03372278 Active, not recruiting - Osteoarthritis, Hip Clinical Trials

PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

Start date: January 2013
Phase:
Study type: Observational

This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.

NCT ID: NCT03370913 Active, not recruiting - Hemophilia A Clinical Trials

Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients (BMN 270-301)

BMN 270-301
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

This Phase III clinical study will assess the impact of BMN 270 (compared to FVIII prophylaxis) on the number of bleeding episodes irrespective of exogenous FVIII replacement treatment in the efficacy evaluation period (EEP) (from Week 5 post-BMN 270 infusion (Study Day 33) or the end of FVIII prophylaxis plus the washout period (3 days for products of standard half-life or plasma-derived and 5 days for products of extended half-life), whichever is later, to last visit by the data cut-off for the 2-year analysis, hereafter referred to as "Post FVIII Prophylaxis to Last Visit"). The study will also assess the impact of BMN 270 (compared to FVIII prophylaxis) on: the number of bleeding episodes requiring exogenous FVIII treatment in "Post FVIII Prophylaxis to Last Visit", FVIII activity as measured by chromogenic sustrate assay at Week 104 following intravenous infusion of BMN 270, usage of exogenous FVIII replacement therapy in "Post FVIII Prophylaxis to Last Visit", health-related quality of life patient-reported outcomes at week 104 following intravenous infusion of BMN 270. The study will also evaluate the safety of the BMN 270.

NCT ID: NCT03368664 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

LemKids
Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT. Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).

NCT ID: NCT03368118 Active, not recruiting - Ulcerative Colitis Clinical Trials

Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis

Start date: January 20, 2018
Phase: Phase 2
Study type: Interventional

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study (induction study) and who are willing to continue their treatment.

NCT ID: NCT03366779 Active, not recruiting - Clinical trials for Lumbar Disc Herniation

A Post Marketing Surveillance Study

6MM
Start date: January 16, 2018
Phase: Phase 4
Study type: Interventional

This study is a prospective, multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used as an adjunct to limited discectomy.

NCT ID: NCT03366272 Active, not recruiting - Clinical trials for Lymphoma, Non-Hodgkin

Nivolumab With Gemcitabine, Oxaliplatin + Rituximab in r/r Elderly Lymphoma Patients

NIVEAU
Start date: December 5, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma

NCT ID: NCT03364868 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)

Start date: February 7, 2018
Phase: Phase 2
Study type: Interventional

The GPPAD-POInT Study is designed as a randomized, placebo-controlled, double blind, multicentre, multinational primary prevention phase IIb study aiming to induce immune tolerance to beta-cell autoantigens through regular exposure to oral insulin for a period of 29 to 32 months. The hypothesis is that regular exposure to oral insulin throughout the period in life where beta-cell autoimmunity usually initiates will tolerize against insulin and train the body's immune system to recognize the treatment product without reacting adversely to it in a manner seen in children who develop T1D. This immune tolerance induction therapy would reduce the likelihood of beta-cell autoimmunity. The study objective is to determine whether daily administration of oral insulin from age 4 months - 7 months until age 3.00 years to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies and diabetes in childhood.

NCT ID: NCT03355209 Active, not recruiting - Clinical trials for Lennox Gastaut Syndrome

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

NCT ID: NCT03353831 Active, not recruiting - Clinical trials for Recurrent Ovarian Carcinoma

Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer

Start date: September 11, 2018
Phase: Phase 3
Study type: Interventional

This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.

NCT ID: NCT03349996 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

Belgian Trial Investigating the LifeStream Stent in Complex TASC C and D Iliac Lesions

BELSTREAM
Start date: October 31, 2017
Phase: N/A
Study type: Interventional

The BELSTREAM Trial investigates the efficacy of the LifeStream Peripheral Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC C and D). An expected total of 70 patients will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the LifeStream Peripheral Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24 ,36 ,48 and 60-month post-procedure. .The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1 ,6 ,24 ,36 ,48 and 60 month, stent graft occlusion rate at pre-discharge, 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, anke-brachial index (ABI) at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, amputation rate at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, technical success and clinical success at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up.