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NCT ID: NCT03000439 Completed - Clinical trials for Arthritis Juvenile Idiopathic

A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

Start date: May 10, 2018
Phase: Phase 3
Study type: Interventional

A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. An interim analysis for efficacy and futility will be conducted when at least 20 flares have been observed. If either criterion is met, the study will be stopped. If neither criterion is met, the study will continue until the requisite number of flares are observed as determined by the number of flares included in the interim analysis and a statistical penalty for conducting the interim analysis.

NCT ID: NCT02914184 Completed - Clinical trials for Infections, Rotavirus

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Start date: October 27, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

NCT ID: NCT02847637 Completed - Hemophilia A Clinical Trials

A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors

HAVEN 3
Start date: September 27, 2016
Phase: Phase 3
Study type: Interventional

This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.

NCT ID: NCT02795767 Completed - Hemophilia A Clinical Trials

A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors

HAVEN 2
Start date: July 22, 2016
Phase: Phase 3
Study type: Interventional

This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.

NCT ID: NCT02789540 Completed - Clinical trials for Stable COPD Patients

Latin American Study of 24-hs Symptoms in Chronic Obstructive Pulmonary Disease (COPD) Patients; LASSYC Study

LASSYC
Start date: June 10, 2016
Phase: N/A
Study type: Observational

This is a multi-country, multicentre, observational prospective data collection cross sectional study of patients with stable COPD in Latin America. Primary objective is to assess and characterize COPD symptoms over a period of 24 hours, by collecting information about the respiratory symptoms experienced at different times of the day and night-time in patients with stable COPD under real clinical practice conditions. Correlation between each of these symptoms and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification, adherence to respiratory treatment, level of dyspnea, disease severity, comorbidities and physical activity as well direct costs will be done as secondary objectives. Study population are patients of 40 years and older, smokers or ex smokers of >= 10 pack/years with previous COPD diagnosis, attending outpatient specialists consults in Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico. Sample size is targeted to 900 enroled patients in order to ensure 860 patients to achieve statistical power to primary objective.

NCT ID: NCT02697734 Completed - Cushing's Disease Clinical Trials

Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease

LINC-4
Start date: October 3, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy.

NCT ID: NCT02626221 Completed - Chronic Urticaria Clinical Trials

A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)

AWARE-LACan
Start date: December 24, 2014
Phase:
Study type: Observational [Patient Registry]

This is a non-interventional, multi-country, Latin American study utilizing a prospective single-cohort design. Eligible CU patients will be enrolled in the study and will be followed for 24 months (± 6 weeks). In accordance with the observational nature of the study, there will be no interventions or interference with the routine care of the patient which will be based solely on the clinical judgment of the treating physician. However, with respect to the frequency and schedule of assessments, the schedule included in Table 7-1 will be recommended. The selection of the treatment for CU will be clearly separated from the decision to include the patient in the study, and will be made at the discretion of the treating physician in accordance with standard medical practice, the investigator's clinical judgment, and global urticarial guidelines. In order to prevent selection bias, investigators should offer enrollment to all consecutive patients meeting study criteria, likely to be available for the full duration of the follow-up period of 24 months, and willing to participate in the study. The overall objective of the study is to evaluate in real-life the CU disease burden, the current treatment patterns and the use of health care resources in patients refractory to H1-antihistamine treatment

NCT ID: NCT02622321 Completed - Hemophilia A Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors

HAVEN 1
Start date: November 18, 2015
Phase: Phase 3
Study type: Interventional

This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of prophylactic emicizumab treatment in participants previously treated with episodic or prophylactic bypassing agents. Episodic bypassing agent participants will be randomized in a 2:1 fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will be stratified across Arms A and B according to the number of bleeds they experienced over the last 24 weeks prior to study entry (less than [<] 9 or greater than or equal to [>/=] 9 bleeds); Arm B participants will have the opportunity to switch to emicizumab prophylaxis after at least 24 weeks on-study. Prophylactic bypassing agent participants will switch to emicizumab prophylaxis (Arm C) from the start of the trial; enrollment will be extended for 24 weeks after the last participant has enrolled in Arms A or B or until approximately 50 participants have enrolled in Arm C, whichever occurs first. Episodic bypassing agent participants who previously participated in the non-interventional study BH29768 (NCT02476942) who were unable to enroll in Arms A or B, or participants on prophylactic bypassing agents who were unable to enroll in Arm C, prior to their closure will have the opportunity to enroll in Arm D. Like participants in Arms A and C, Arm D participants will receive emicizumab prophylaxis from the start of the trial. All participants will continue to receive episodic bypassing agent therapy to treat breakthrough bleeds, preferably with recombinant activated factor VII (rFVIIa).

NCT ID: NCT02550652 Completed - Lupus Nephritis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

Start date: November 13, 2015
Phase: Phase 2
Study type: Interventional

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

NCT ID: NCT02486237 Completed - Clinical trials for Diabetes Mellitus, Type 2

Complications in Central American Diabetic Patients: Historic Cohort

Start date: September 2015
Phase: N/A
Study type: Observational

Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients.