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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: 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: March 15, 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

NCT ID: NCT02629159 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

SELECT-COMPARE
Start date: December 1, 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind study comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a stable background of Methotrexate (MTX) and who have an inadequate response to MTX.