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NCT ID: NCT02788279 Completed - Colorectal Cancer Clinical Trials

A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

Start date: July 5, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, open-label, three-arm, randomized study in participants with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to cobimetinib plus atezolizumab and atezolizumab monotherapy.

NCT ID: NCT02786758 Completed - HIV Clinical Trials

Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals

co-EC
Start date: April 2016
Phase:
Study type: Observational

This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV) in individuals co-infected with HIV could lead to elimination of HCV/HIV co-infection in gay and bisexual men by treating prevalent infection, thereby reducing new primary infections and re-infection.

NCT ID: NCT02783833 Completed - Malaria Clinical Trials

MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part B

Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P. falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P. falciparum (Part B).

NCT ID: NCT02783820 Completed - Malaria Clinical Trials

Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A

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

This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).

NCT ID: NCT02782741 Completed - Clinical trials for Glycogen Storage Disease Type II;Pompe's Disease

Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease

COMET
Start date: November 2, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12).

NCT ID: NCT02782104 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

SUSTAIN-3
Start date: June 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).

NCT ID: NCT02781727 Completed - Clinical trials for Endocrine System Diseases

A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Start date: December 13, 2016
Phase: Phase 3
Study type: Interventional

A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females) with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH : Genotropin). This is a global trial that will be conducted in Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and the United States.

NCT ID: NCT02780167 Completed - Atopic Dermatitis Clinical Trials

Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis

Start date: April 2016
Phase: Phase 2
Study type: Interventional

Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.

NCT ID: NCT02777008 Completed - Healthy Clinical Trials

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects

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

Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.

NCT ID: NCT02776072 Completed - Multiple Sclerosis Clinical Trials

Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)

EFFECT
Start date: May 2016
Phase: N/A
Study type: Observational

The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF). Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.