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NCT ID: NCT01972568 Completed - Clinical trials for Lupus Erythematosus, Systemic

Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

ADDRESS II
Start date: December 2013
Phase: Phase 2
Study type: Interventional

This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

NCT ID: NCT01972529 Completed - Clinical trials for Thrombocytopenia Associated With Liver Disease

Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure

Start date: February 2014
Phase: Phase 3
Study type: Interventional

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

NCT ID: NCT01972282 Completed - Clinical trials for Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke

Registry on WATCHMAN Outcomes in Real-Life Utilization

EWOLUTION
Start date: October 28, 2013
Phase:
Study type: Observational [Patient Registry]

The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

NCT ID: NCT01972217 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.

Start date: April 1, 2014
Phase: Phase 2
Study type: Interventional

This is a 2-part study in patients with metastatic CRPC. Part A is an open-label safety run-in study to assess the safety, tolerability and pharmacokinetics (PK) of olaparib when given in addition to abiraterone 1000 mg once daily. Part B is a randomised, double-blind, placebo controlled comparison of the efficacy, safety and tolerability of the dose of olaparib selected from Part A when given in addition to abiraterone, versus placebo given in addition to abiraterone. Abiraterone is indicated in combination with prednisone or prednisolone for the treatment of patients with metastatic CRPC. Prednisone or prednisolone 5 mg twice daily (bid) will be administered with the abiraterone in this study.

NCT ID: NCT01971762 Completed - Clinical trials for Staphylococcus Aureus Bacteremia

Staphylococcus Aureus Bacteremia: Impact of an Intervention Program in Improving the Clinical Management and Review of the Clinical and Molecular Epidemiology

Start date: April 2011
Phase: N/A
Study type: Observational

Staphylococcus aureus bacteremia: impact of an intervention program in improving the clinical management and review of the clinical and molecular epidemiology.

NCT ID: NCT01970865 Completed - Clinical trials for ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

Start date: January 8, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients .

NCT ID: NCT01970553 Completed - Clinical trials for Specific Advanced Solid Tumors

Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors

Start date: May 2011
Phase: Phase 1
Study type: Interventional

Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with gemcitabine, to characterize the safety profile and feasibility of this combination in patients with selected advanced solid tumors, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed, in order to assess potential markers of response and/or resistance.

NCT ID: NCT01970540 Completed - Clinical trials for Neuroendocrine Tumors

Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Start date: May 25, 2011
Phase: Phase 1
Study type: Interventional

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types [i.e. small cell lung cancer (SCLC) and endometrial cáncer] and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance.

NCT ID: NCT01970475 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

RA
Start date: October 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety of ABP 501 against Adalimumab (Humira®) in adult subjects with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).

NCT ID: NCT01969838 Completed - Clinical trials for Primary Myelofibrosis

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Simplify 1
Start date: December 6, 2013
Phase: Phase 3
Study type: Interventional

This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor). Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.