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NCT ID: NCT02655614 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

A Study of GDC-0134 to Determine Initial Safety, Tolerability, and Pharmacokinetic Parameters in Participants With Amyotrophic Lateral Sclerosis

Start date: May 31, 2016
Phase: Phase 1
Study type: Interventional

This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and pharmacokinetic (PK) properties of GDC-0134. It will include three components: a Single-Ascending-Dose (SAD) stage, a Multiple-Ascending-Dose (MAD) stage, and an Open-Label Safety Expansion (OSE) stage.

NCT ID: NCT02655315 Completed - Parkinson Disease Clinical Trials

Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease

FAIRPARKII
Start date: February 9, 2016
Phase: Phase 2
Study type: Interventional

This study evaluates the effect of iron chelation as a therapeutic strategy to slow the progression of Parkinson's disease. Half of participants will receive the deferiprone to 15 mg / kg twice daily morning and evening (30mg / kg per day), while the other half will receive a placebo. The treatment lasts nine months.

NCT ID: NCT02654990 Completed - Multiple Myeloma Clinical Trials

Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma

PANORAMA_3
Start date: April 27, 2016
Phase: Phase 2
Study type: Interventional

NOTE: The study data was transferred to zr pharma& following the divestment of Panobinostat to pharma&. Prior to study completion under the sponsorship of Secura Bio, the study was initiated and conducted in part under the sponsorship of Novartis. The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression. Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons. Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks. All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3-year survival follow-up or discontinued earlier.

NCT ID: NCT02654821 Active, not recruiting - Clinical trials for Stage IV Skin Melanoma

Study With T-cel Receptor Gene Therapy in Metastatic Melanoma

TCR
Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with stage IV melanoma (also eye melanoma) will be treated with TCR transduced cells.

NCT ID: NCT02654678 Not yet recruiting - Heart Failure Clinical Trials

Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril

LENA-WP10
Start date: March 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric long-term safety follow-up clinical trial in maximum 100 children with heart failure due to dilated cardiomyopathy or congenital heart disease, from 1 day to less than 12 years of age at recruitment into the preceding short-term pharmacokinetic (PK)/pharmacodynamic (PD) trials. Pharmacodynamic measurements and renal monitoring in all children after 1 , 4, 7 and 10 months of follow-up; in addition PK assessments as well as acceptability and palatability assessments in children still under enalapril Orodispersible Minitablet (ODMT) treatment.

NCT ID: NCT02654470 Completed - Clinical trials for Non-valvular Atrial Fibrillation

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)

Start date: July 16, 2019
Phase:
Study type: Observational

Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

NCT ID: NCT02654145 Completed - Asthma Clinical Trials

Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients

Start date: March 17, 2016
Phase: Phase 4
Study type: Interventional

Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE) monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic asthma. The aim of this study is to investigate whether subjects not optimally controlled on their current omalizumab treatment, who are eligible for therapy with mepolizumab can be effectively and safely switched to treatment with mepolizumab to improve asthma control. The study will provide data on the efficacy, safety, immunogenicity, and tolerability of mepolizumab when switched directly from omalizumab without any wash-out. The learnings from this study may help guide physicians when substituting one biologic with another for the treatment of patients with severe eosinophilic asthma. The study will be a multi-centre, open-label single arm trial. Patients with severe eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be eligible to participate. Subjects will remain on their current maintenance therapy including omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit 2 (week 0) subjects will discontinue their omalizumab treatment and be switched to mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32 weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last dose of mepolizumab.

NCT ID: NCT02654132 Completed - Multiple Myeloma Clinical Trials

An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)

Start date: March 18, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.

NCT ID: NCT02652741 Not yet recruiting - Heart Failure Clinical Trials

Orodispersible Minitablets of Enalapril in Young Children With Heart Failure Due to Congenital Heart Disease

LENA-WP09
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric clinical trial in 50 children, from newborn to less than 6 years of age, suffering from heart failure due to congenital heart disease, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.

NCT ID: NCT02652728 Not yet recruiting - Heart Failure Clinical Trials

Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy

LENA-WP08
Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Paediatric clinical trial in 50 children, from 1 month to less than 12 years of age, suffering from heart failure due to dilated cardiomyopathy, to obtain paediatric pharmacokinetic and pharmacodynamic data of enalapril and its active metabolite enalaprilat while treated for 8 weeks with enalapril in form of Orodispersible Minitablets (ODMTs), to describe the dose exposure in this patient population.