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NCT ID: NCT03038100 Completed - Ovarian Cancer Clinical Trials

A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

IMagyn050
Start date: March 8, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

NCT ID: NCT03037411 Completed - Atherosclerosis Clinical Trials

A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries

REGAL
Start date: December 13, 2016
Phase:
Study type: Observational

The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

NCT ID: NCT03037385 Completed - Neoplasms Clinical Trials

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

ARROW
Start date: March 17, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of pralsetinib (BLU-667) administered orally in participants with medullary thyroid cancer (MTC), RET-altered NSCLC and other RET-altered solid tumors.

NCT ID: NCT03036839 Completed - Clinical trials for Hepatitis C Virus Infection

Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease

ESRD
Start date: June 27, 2017
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.

NCT ID: NCT03036813 Completed - Sickle Cell Disease Clinical Trials

Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)

GBT_HOPE
Start date: December 2016
Phase: Phase 3
Study type: Interventional

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease

NCT ID: NCT03036462 Completed - Iron Deficiency Clinical Trials

Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality

FAIR-HF2
Start date: February 7, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether intravenous iron supplementation using ferric carboxymaltosis (FCM) reduces hospitalisation and mortality in patients with iron deficiency and heart failure.

NCT ID: NCT03035864 Completed - Ocular Discomfort Clinical Trials

A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery

Start date: January 12, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this exploratory study is to assess preliminary efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery. The main criteria for evaluation were: - Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of treatment (primary efficacy endpoint) - Changes in Cornea vital staining with fluorescein (National Eye Institute [NEI] scales) assessed at 8 weeks of treatment (co-primary efficacy endpoint) - Changes in conjunctiva vital staining with fluorescein (NEI scales) (secondary efficacy endpoint); - Changes in Tear Film Break-Up Time (TFBUT)(secondary efficacy endpoint); - Changes in Cochet-Bonnet corneal aesthesiometry (secondary efficacy endpoint); - Changes in Nerve count and morphology at scanning laser in vivo corneal confocal microscopy (only patients who had Laser-Assisted In situ Keratomileusis [LASIK] surgery) (secondary efficacy endpoint); - Changes in SANDE scores (face values) for severity and frequency (secondary efficacy endpoint); - Incidence and frequency of treatment-emergent adverse events (TEAEs), assessed throughout the study (safety endpoint).

NCT ID: NCT03035721 Completed - Safety Issues Clinical Trials

Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT

Start date: June 2014
Phase: N/A
Study type: Interventional

This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.

NCT ID: NCT03034915 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 16, 2017
Phase: Phase 4
Study type: Interventional

COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance. This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks. Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week. ELLIPTA and DISKUS are trademarks of GSK group of companies.

NCT ID: NCT03033121 Completed - Clinical trials for Growth Hormone Treatment

Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

GH 3 wk dose
Start date: January 1, 2016
Phase: Phase 3
Study type: Interventional

Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.