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NCT ID: NCT03102593 Completed - Clinical trials for Primary Immune Thrombocytopenia

A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP

Start date: March 13, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia.

NCT ID: NCT03102567 Completed - Healthy Clinical Trials

This is a Study to Evaluate the Effect of Aging of Multiple Doses of GLPG1205 in Healthy Subjects

Start date: October 18, 2016
Phase: Phase 1
Study type: Interventional

This study is a Phase I, single-center, randomized, double-blind, placebo-controlled study to evaluate the effect of aging on safety, tolerability and PK of multiple oral doses of GLPG1205 in healthy male subjects. The study will comprise of 2 parts, a first part to investigate the effect of aging and a second part to investigate the effect of a loading dose.

NCT ID: NCT03102320 Completed - Neoplasms Clinical Trials

Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors

ARCS-Multi
Start date: May 26, 2017
Phase: Phase 1
Study type: Interventional

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.

NCT ID: NCT03101670 Completed - Psoriatic Arthritis Clinical Trials

A Study to Assess Efficacy and Safety of Filgotinib in Active Psoriatic Arthritis

EQUATOR
Start date: March 9, 2017
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 weeks (from Screening visit to Follow-up visit).

NCT ID: NCT03101644 Completed - Clinical trials for Human Immunodeficiency Virus I Infection

Optimization of Darunavir Therapy and Dosage Recommendations

Start date: March 23, 2017
Phase: Phase 4
Study type: Interventional

This study will assess and characterize the variability observed in the response to darunavir therapy, an antiretroviral medication used against the Human Immunodeficiency Virus (HIV). More specifically, it aims to quantify variations in the drug's blood concentrations and determine the sources of such variability, both genetic and non-genetic. In light of this information, current dosage guidelines will then be reviewed.

NCT ID: NCT03100903 Completed - Healthy Clinical Trials

Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects

Start date: April 24, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this trial is to investigate the relative bioavailability of BI 655130 following subcutaneous administration (Test, T) compared to BI 655130 following intravenous infusion (Reference, R). The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between all tested treatments.

NCT ID: NCT03100864 Completed - Colitis, Ulcerative Clinical Trials

This Study Tests How BI 655130 Works in Patients With Active Ulcerative Colitis. The Study Also Tests How Well BI 655130 is Tolerated and Whether it Helps the Patients

Start date: May 22, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to understand the mechanism of action of BI655130 in patients with UC Secondary objectives are to explore clinical effect, safety and tolerability (including immunogenicity) of BI 655130 treatment

NCT ID: NCT03100669 Completed - Postoperative Pain Clinical Trials

Implementing a Postoperative MIRP (Minimally Invasive Repair of Pectus) Program Via Tele-monitoring

Start date: May 1, 2017
Phase:
Study type: Observational [Patient Registry]

MIRP (Minimally Invasive Repair of Pectus) as surgical correction of pectus excavatum or carinatum is performed to achieve physiological, cosmetic, and psychological benefits for the patient. Surgery is often associated with severe postoperative pain. In this study the researchers want to registrate pain, sleep, nausea/vomiting, and daily activities in short and long term follow up.

NCT ID: NCT03100448 Completed - Implant Clinical Trials

A 1-year Clinical Investigation on the On1 Concept

T-190
Start date: February 24, 2017
Phase: N/A
Study type: Interventional

A 1-year Clinical Investigation on the On1 Concept.

NCT ID: NCT03100032 Completed - Spondylolisthesis Clinical Trials

Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis

Spine1
Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

A prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion (L1 - S1).