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NCT ID: NCT03439670 Completed - Clinical trials for Duchenne Muscular Dystrophy

A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

Start date: June 29, 2018
Phase: Phase 2
Study type: Interventional

Brief Summary: This Phase IIb study is a randomized, double-blind, parallel group, placebo and active-controlled study to evaluate the efficacy, safety, PD, and population PK of vamorolone administered orally at daily doses of 2.0 mg/kg and 6.0 mg/kg versus prednisone 0.75 mg/kg/day and placebo over a Treatment Period of 24 weeks, and to evaluate persistence of effect over a Treatment Period of 48 weeks in ambulant boys ages 4 to <7 years with DMD.

NCT ID: NCT03439254 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

REVERSE
Start date: August 30, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

NCT ID: NCT03434379 Completed - Clinical trials for Carcinoma, Hepatocellular

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

IMbrave150
Start date: March 15, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

NCT ID: NCT03433027 Completed - Clinical trials for Head and Neck Squamous Cell Carcinoma

A Study of BB-401 in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Start date: March 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and efficacy of intratumoral injections with an Epidermal Growth Factor Receptor (EGFR) AntiSense DNA (BB-401) in patients with metastatic/recurrent HNSCC.

NCT ID: NCT03432351 Completed - General Anesthesia Clinical Trials

Multi-center Isoelectric EEG Study in Children Under General Anesthesia

Start date: June 21, 2018
Phase:
Study type: Observational

Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing general anesthesia.

NCT ID: NCT03431480 Completed - Clinical trials for Heart Defects, Congenital

Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery

Start date: February 16, 2018
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the safety and feasibility of coronary infusion of autologous placental cord blood mononuclear cells during the Norwood heart operation in newborn hypoplastic left heart syndrome (HLHS) patients.

NCT ID: NCT03429387 Completed - Clinical trials for Acute Myeloid Leukemia

PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia

PIPPIN
Start date: January 8, 2018
Phase: N/A
Study type: Interventional

Patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). The causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated. This study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source of infection. Diagnostic yield, change in management and outcomes will be compared between arms.

NCT ID: NCT03428217 Completed - Clinical trials for Metastatic Renal Cell Carcinoma

CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

CANTATA
Start date: April 24, 2018
Phase: Phase 2
Study type: Interventional

Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).

NCT ID: NCT03427814 Completed - Clinical trials for Advanced or Inoperable Gastric Cancer

Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer

Start date: July 3, 2018
Phase: Phase 2
Study type: Interventional

This study enrolled participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants received BGB-290; in Arm B participants received placebo. The purpose of this study is to show that BGB-290 (pamiparib) (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.

NCT ID: NCT03426592 Completed - Clinical trials for Human Immunodeficiency Virus

Effect of High Dose Vitamin D Supplementation on HIV Latency

VIVA
Start date: January 29, 2018
Phase: Phase 2
Study type: Interventional

HIV persists despite antiretroviral therapy (ART) and is associated with chronic inflammation. This inflammation is thought to prevent an effective immune response against the virus and is mediated at least in part by gut epithelial permeability and microbial translocation. HIV accumulates preferentially within Th17 cells with time on ART; these memory CD4+ T cells are highly susceptible to HIV infection and are concentrated within the gut. Vitamin D promotes gut epithelial integrity in animal models and exerts anti-inflammatory effects on the human immune system including down-modulation of Th17 cell frequency. This study will evaluate whether high dose vitamin D is able to reduce immune activation and Th17 cell frequency, to improve gut barrier integrity and the gut microbiome and reduce HIV persistence in participants on long-term suppressive ART.