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NCT ID: NCT03185897 Completed - Hemophilia A Clinical Trials

Global Epidemiologic Study of Preexisting Immunity to AAV in Adults With Severe Hemophilia

Start date: June 14, 2017
Phase:
Study type: Observational

Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia B (coagulation factor IX [FIX] ≤2%).

NCT ID: NCT03185819 Completed - Clinical trials for Depressive Disorder, Major

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide

Start date: October 5, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.

NCT ID: NCT03185013 Completed - Cervical Dysplasia Clinical Trials

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

REVEAL 1
Start date: June 28, 2017
Phase: Phase 3
Study type: Interventional

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

NCT ID: NCT03184090 Completed - Clinical trials for Metastatic Breast Cancer

Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge in ER+ mBC

BioPER
Start date: June 28, 2017
Phase: Phase 2
Study type: Interventional

This is an international, open-label, non-controlled, multicenter phase II clinical trial with two different primary objectives: a biological and a clinical objective. From a clinical point of view, the objective is to assess the clinical benefit of the combination of palbociclib and hormonotherapy in patients with advance breast cancer that had previously received endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib treatment with subsequent disease progression. From a biological point of view, the challenge is to define a molecular profile that allow identifying patients that could benefit more from continuing on palbociclib after progression on a prior palbociclib-containing regimen

NCT ID: NCT03183271 Completed - Clinical trials for Neuroendocrine Tumors

Proton Boost for Locally Advanced HEAD AND NECK TUMORS

Start date: July 16, 2012
Phase: N/A
Study type: Interventional

The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).

NCT ID: NCT03181633 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Long-Term Treatment Study of ACH-0144471 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start date: June 22, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of ACH-0144471 in participants with paroxysmal nocturnal hemoglobinuria (PNH) who have demonstrated clinical benefit from ACH-0144471 in Study ACH471-100. This study is designed to include up to 12 participants.

NCT ID: NCT03180931 Completed - Clinical trials for Tomography, Optical Coherence

Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis

INVEST
Start date: December 2, 2016
Phase: N/A
Study type: Observational [Patient Registry]

Bioresorbable vascular scaffold (BVS, ABSORB BVS1.1, Abbott Vascular) has been approved (CE mark) and is used in daily clinical practice. While recent randomized controlled trials comparing BVS versus metallic drug-eluting stent showed higher risk of definite or probable device thrombosis after BVS implantation, the causes underlying thrombotic events occurring beyond one year after scaffold implantation remain unclear and require investigation in an independent manner. The INVEST registry is a world-wide, multi-center, observational, retrospective, investigator-initiated registry, which will include any patients who suffered from very late (>1 year) scaffold thrombosis, underwent optical coherence tomography (OCT) at the time of thrombosis and provided informed consent for the further use of their health related data for this registry.

NCT ID: NCT03180840 Completed - Fabry Disease Clinical Trials

Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks

BRIGHT
Start date: July 10, 2017
Phase: Phase 3
Study type: Interventional

This open-label switchover study will assess the safety, efficacy, and pharmacokinetics of pegunigalsidase alfa (PRX-102) 2 mg/kg administered every 4 weeks for 52 weeks in Fabry patients previously treated with ERT: agalsidase alfa or agalsidase beta for at least 3 years. Safety and efficacy exploratory endpoints will be evaluated throughout the study period and pharmacokinetics will be obtained on Day 1 and Week 52.

NCT ID: NCT03180619 Completed - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)

Start date: June 29, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.

NCT ID: NCT03179436 Completed - Clinical trials for Advanced Solid Tumors

Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001)

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

This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.