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NCT ID: NCT03496207 Completed - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)

PULSAR
Start date: June 13, 2018
Phase: Phase 2
Study type: Interventional

Study A011-09 is designed to assesses the efficacy and safety of sotatercept (ACE-011) relative to placebo in adults with pulmonary arterial hypertension (PAH). Eligible participants will receive study treatment for 24 weeks during the placebo-controlled treatment period, and then will be eligible to enroll into a 30-month extension period during which all participants will receive sotatercept. All treated patients will also undergo a follow-up period after last study drug treatment.

NCT ID: NCT03495882 Completed - Cervical Cancer Clinical Trials

Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)

Start date: December 18, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label study of AGEN1884 in combination with AGEN2034 in subjects with locally advanced, recurrent and/or metastatic solid tumors including cervical cancer. AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) antibody, designed to block program cell death-1 (PD-1). AGEN1884 is a novel, fully human monoclonal immunoglobulin G1 (IgG1) antibody, designed to block cytotoxic T-lymphocyte antigen-4 (CTLA-4).

NCT ID: NCT03495765 Completed - Clinical trials for Diabetic Macular Oedema

To Evaluate the Comparative Efficacy of Lucentis (Ranibizumab) 0.5mg Intravitreal Injection in Patients With Diabetic Macular Oedema (DME) With Well Controlled and Poorly Controlled Diabetes Mellitus

CONTROL
Start date: March 2011
Phase: Phase 3
Study type: Interventional

To demonstrate the comparative effectiveness of 12 months of Lucentis (ranibizumab) in patients with well controlled compared to those with poorly controlled diabetes using an PRN treatment schedule.

NCT ID: NCT03494920 Completed - Ischemic Stroke Clinical Trials

DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval Versus Standard Bridging Thrombolysis With Endovascular Clot Retrieval

Start date: April 27, 2018
Phase: Phase 3
Study type: Interventional

The study will be a multicentre, prospective, randomized, open label, blinded endpoint (PROBE) phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients within 4.5 hours of stroke onset. Randomised patients will be stratified for site of baseline arterial occlusion into one of three groups: 1. internal carotid artery (ICA) 2. middle cerebral artery (MCA) 3. basilar artery (BA). Patients will be randomised to either bridging intravenous thrombolysis with endovascular clot retrieval (ECR), or direct endovascular clot retrieval.

NCT ID: NCT03493919 Completed - Clinical trials for Meningitis, Meningococcal

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

Start date: March 8, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study was to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine (Bexsero), which serves for the development, qualification, validation, and maintenance of immunological assays which supports the preclinical research activities and clinical development of GSK Biologicals' vaccines. The safety of the subjects given one of the two vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during their participation in the study.

NCT ID: NCT03493646 Completed - Clinical trials for Acute Myeloid Leukemia

Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486

Start date: May 18, 2018
Phase: Phase 2
Study type: Interventional

Myelodysplastic Syndrome (MDS) is a group of blood disorders where the bone marrow does not produce enough mature red blood cells, white blood cells and platelets. In a healthy person, the bone marrow makes blood stem cells (immature cells, also called 'blasts') that become mature blood cells over time. In people with MDS, this process is affected and immature blood cells in the bone marrow do not mature fully to become healthy blood cells. This causes a lack of healthy blood cells that can function properly. With fewer healthy blood cells, infection, anaemia, or easy bleeding may occur. MDS can progress to acute myeloid leukaemia in 25-30% of patients, and if untreated it can be rapidly fatal. The purpose of this study is to evaluate the standard treatment, azacitidine (Vidaza) given as an injection under the skin compared to the same medication (called CC-486) taken as a tablet by mouth. Vidaza is approved by the Australian Therapeutics Goods Administration (TGA) as standard treatment for MDS. CC-486 is an experimental treatment. This means it is not an approved treatment for MDS in Australia. CC-486 is being developed to increase convenience and make it easier for patients to continue their treatment. So far it has been given to over 870 patients in studies across the world. The treatment in the injection and the tablet is the same. Studies like this one are being done to ensure the tablet works in the same way as the standard injected treatment. Vidaza is given by subcutaneous injection (ie under the skin) over an hour for 7 days every 4 weeks for as long as it continues to work. All study participants will receive active treatment (there is no placebo), and all participants will receive the standard injection for six treatment cycles followed by the new tablet medication taken once daily for 21 days every 4 weeks. This allows the researchers to compare the two ways of giving the medicine.

NCT ID: NCT03493191 Completed - Acute Pain Clinical Trials

A Single Dose Study of SHR0410 in Healthy Male Participants

Start date: April 15, 2018
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, single ascending-dose study to investigate the effect of a single intravenous (IV) dose of SHR0410 at 6 dose levels (0.5 μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.

NCT ID: NCT03492112 Completed - Hepatitis C Clinical Trials

A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams

TEMPO
Start date: September 10, 2019
Phase: N/A
Study type: Interventional

TEMPO is an interventional cohort study recruiting injecting drug users attending needle and syringe programs (NSP) in Australia. Three hundred participants will be invited to on-site HCV testing with NSP integrated care for HCV treatment. Participants will be screened for HCV using point-of-care testing and HCV positive participants will be offered treatment with Sofosbuvir/Velpatasvir. Of those who initiate treatment, participants will receive weekly peer-based support on-treatment and return at End of Treatment (ETR) and 12 weeks following end of treatment (SVR12) for clinical follow-up.

NCT ID: NCT03491748 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants

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

This research project is being conducted to investigate the safety, tolerability, and pharmacokinetics (PK) of a single ascending dose (SAD) and multiple ascending doses (MAD) of oral ETX0282 when administered alone and in combination with cefpodoxime proxetil in healthy adult participants.

NCT ID: NCT03490201 Completed - Clinical trials for Ventricular Tachycardia

FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study

LESS-VT
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.