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NCT ID: NCT03519243 Active, not recruiting - Anemia Clinical Trials

Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis

Start date: October 24, 2017
Phase: Phase 2
Study type: Interventional

BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.

NCT ID: NCT03021499 Active, not 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: NCT03013504 Active, not recruiting - Clinical trials for HER2 Positive Breast Cancer

A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

TROIKA
Start date: January 1, 2018
Phase: Phase 3
Study type: Interventional

In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.

NCT ID: NCT03011450 Active, not recruiting - Clinical trials for Severe Hypertriglyceridemia

Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment

Start date: November 26, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.

NCT ID: NCT03001817 Active, not recruiting - Clinical trials for Severe Hypertriglyceridemia

Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function

Start date: November 28, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with fasting high triglyceride levels ≥500 mg/dL and <2000 mg/dL and normal renal function.

NCT ID: NCT02968004 Active, not recruiting - Clinical trials for Pediatric Growth Hormone Deficiency

Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Start date: December 2016
Phase: Phase 3
Study type: Interventional

This will be an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.

NCT ID: NCT02871635 Active, not recruiting - Crohn Disease Clinical Trials

BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

Start date: September 28, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD). Secondary Objectives: The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.

NCT ID: NCT02810457 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer

AVANA
Start date: June 2016
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer

NCT ID: NCT02754882 Active, not recruiting - Lung Cancer Clinical Trials

A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

Start date: June 2016
Phase: Phase 3
Study type: Interventional

This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

NCT ID: NCT02706873 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

SELECT-EARLY
Start date: February 23, 2016
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX) monotherapy in MTX-naïve subjects with moderately to severely active rheumatoid arthritis