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NCT ID: NCT03409107 Completed - Anaemia Clinical Trials

Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)

Start date: March 5, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.

NCT ID: NCT03407482 Terminated - Clinical trials for Lupus Erythematosus, Systemic

An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Start date: January 9, 2018
Phase: Phase 2
Study type: Interventional

This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.

NCT ID: NCT03407144 Active, not recruiting - Hodgkin Lymphoma Clinical Trials

Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)

Start date: April 9, 2018
Phase: Phase 2
Study type: Interventional

This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.

NCT ID: NCT03405714 Completed - Epilepsy Clinical Trials

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy

Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.

NCT ID: NCT03400852 Terminated - Clinical trials for Muscular Dystrophy, Duchenne

A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy

BRAVE
Start date: July 27, 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).

NCT ID: NCT03398148 Completed - Clinical trials for Ulcerative Colitis (UC)

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Start date: March 7, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

NCT ID: NCT03398135 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

Start date: August 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.

NCT ID: NCT03397485 Completed - Undernutrition Clinical Trials

Fortified Milk, Growth and Micronutrient Status in Mexican Toddlers (MilkGrowth)

Start date: January 1, 2011
Phase: N/A
Study type: Interventional

The objective of the present study was to assess the effect of a growing-up milk on growth and micronutrient status in children 12 to 30 months of age. The study was conducted in Cuernavaca, the state capital of Morelos, Mexico. The investigators included children who attended day-care centers. These day- care centers are part of a national government program which main objective is to support working mothers and those who intend to work and do not have access to a health service and are at risk of poverty. The study described herein is a randomized, parallel, double-blind, controlled trial by administration of growing up milk (GM) and fortified milk (FM). Results showed a significant improvement in linear growth in both supplemented groups, with no statistical difference between treatments. By using an artificial, population-based comparison group, the investigators conclude that this improvement was attributable to the supplements.

NCT ID: NCT03393286 Completed - Zika Virus Clinical Trials

ZIKAlliance Children Cohort (ZIKAllianceCH)

ZIKAllianceCH
Start date: January 15, 2018
Phase:
Study type: Observational

The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV) infections in pregnancy and congenital malformations. The study will estimate the absolute and relative risks of congenital malformations and other adverse outcomes of pregnancy among women who become infected with ZIKV during pregnancy compared to uninfected pregnant women, also leading to further validation of the Congenital Zika Syndrome.

NCT ID: NCT03393013 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis

MISSION
Start date: February 20, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).