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NCT ID: NCT03244085 Recruiting - Chronic Hepatitis b Clinical Trials

A Study to Investigate the Safety, Efficacy and Pharmacokinetic Profile of Multiple Doses of QL-007 in Chronic Hepatitis B Patients

Start date: August 20, 2017
Phase: Phase 1
Study type: Interventional

This is a nonrandomized, open-label, no-control, dose-escalation Phase 1b trial in 18 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of QL-007 after administration over 28 days of multiple oral doses in a fasted state at the following planned dose levels: 200 mg/day (100 mg two times a day (BID)), 400 mg/day (200 mg BID), then 600 mg once daily (QD), with 6 patients for each cohort.

NCT ID: NCT03216005 Recruiting - Clinical trials for Chronic Venous Insufficiency

Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

INFINITE-OUS
Start date: November 2, 2017
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

NCT ID: NCT03212404 Recruiting - Clinical trials for Head and Neck Cancer

Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers

Start date: September 20, 2017
Phase: Phase 1
Study type: Interventional

CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.

NCT ID: NCT03181360 Recruiting - Ischemic Stroke Clinical Trials

Tenecteplase in Wake-up Ischaemic Stroke Trial

TWIST
Start date: June 12, 2017
Phase: Phase 3
Study type: Interventional

Stroke is a leading causes of death and disability. At least 20% of strokes occur during sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy. Previous studies indicate that many wake-up strokes occur just before awakening. In this study, patients with wake-up stroke will be randomized to thrombolysis with tenecteplase and best standard treatment or to best standard treatment without thrombolysis. Tenecteplase has several potential advantages over alteplase, including very rapid action and that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT scan to inform this decision. CT is used as a routine examination in all stroke patients. Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more complex brain scans, which are not routinely available in the emergency situation in all hospitals.

NCT ID: NCT03178552 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

B-FAST
Start date: September 22, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

NCT ID: NCT03153449 Recruiting - Clinical trials for Primary Knee Arthroplasty

ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Start date: September 19, 2017
Phase: N/A
Study type: Interventional

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in complex primary total knee arthroplasty.

NCT ID: NCT03126266 Recruiting - Clinical trials for Recurrent or Progressive Diffuse Intrinsic Pontine Glioma

Re-Irradiation of Progressive or Recurrent DIPG

Start date: April 15, 2017
Phase: N/A
Study type: Interventional

This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG)

NCT ID: NCT03090789 Recruiting - Friedreich Ataxia Clinical Trials

FA Clinical Outcome Measures

FA-COMS
Start date: January 1, 2001
Phase:
Study type: Observational [Patient Registry]

This multicenter natural history study aims to expand the network of clinical research centers in FA, and to provide a framework for facilitating therapeutic interventions. In addition, this study will lead to the development of valid yet sensitive clinical measures crucial to outcome assessment of patients with Friedreich's Ataxia. This study will support genetic modifier studies, biomarker studies, and frataxin protein level assessments by building a sample repository.

NCT ID: NCT03083327 Recruiting - Clinical trials for Hematologic Neoplasms

Prophylactic Early PN in HPT/BMT

Start date: November 23, 2017
Phase: N/A
Study type: Interventional

Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell transplant.

NCT ID: NCT03075696 Recruiting - Clinical trials for Non-Hodgkin's Lymphoma

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Start date: February 21, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-to-human study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.