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NCT ID: NCT03303313 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

A Study of an Investigational Drug, Cemdisiran (ALN-CC5), in Patients With Atypical Hemolytic Uremic Syndrome

Start date: September 19, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Cemdisiran in patients with aHUS.

NCT ID: NCT03023020 Recruiting - Clinical trials for Coronary Artery Disease

Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen

MASTER DAPT
Start date: April 4, 2017
Phase: N/A
Study type: Interventional

The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube). This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.

NCT ID: NCT03021499 Recruiting - Lupus Nephritis Clinical Trials

Aurinia Renal Response in Active Lupus With Voclosporin

AURORA
Start date: May 17, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

NCT ID: NCT02978716 Recruiting - Breast Cancer Clinical Trials

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

Start date: January 2017
Phase: Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients with metastatic triple negative breast cancer. The study is open-label and approximately 90 patients will be randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups: - Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30) - Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=30) - Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=30) The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.

NCT ID: NCT02870972 Recruiting - Clinical trials for Hereditary Angioedema (HAE)

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema

APeX-1
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.

NCT ID: NCT02828683 Active, not recruiting - Clinical trials for Acute ST Segment Elevation Myocardial Infarction

Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study

MASTER
Start date: July 2013
Phase: N/A
Study type: Interventional

The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.

NCT ID: NCT02735044 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

EDITION JUNIOR
Start date: April 14, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c) Secondary Objectives: - To compare HOE901-U300 and Lantus in terms of: - Percentage of patients reaching target HbA1c and fasting plasma glucose (FPG). - To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.

NCT ID: NCT02663323 Recruiting - Clinical trials for Coronary Artery Disease

Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

MeRes-1 Extend
Start date: February 2016
Phase: Phase 2/Phase 3
Study type: Interventional

MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure.

NCT ID: NCT02620566 Completed - Anesthesia Clinical Trials

Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

CBvsLWI
Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).

NCT ID: NCT02518620 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

An Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Rheumatoid Arthritis

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the long-term efficacy and safety of ALX-0061 administered subcutaneously (s.c.) to subjects with active Rheumatoid Arthritis (RA).