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NCT ID: NCT04659863 Active, not recruiting - Clinical trials for Familial Hypercholesterolemia - Homozygous

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

ORION-13
Start date: February 16, 2021
Phase: Phase 3
Study type: Interventional

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).

NCT ID: NCT04659603 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors

CARMEN-BT01
Start date: March 29, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: - For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) - For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine Secondary Objectives: - To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine - To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine - To assess the immunogenicity of tusamitamab ravtansine - To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination

NCT ID: NCT04658472 Active, not recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Start date: April 28, 2021
Phase: Phase 2
Study type: Interventional

Primary Objectives: - Part A: Efficacy of SAR445088 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive - Part B:Long-term safety and tolerability of SAR445088 in CIDP Secondary Objectives: - Part A: - Safety and tolerability of SAR445088 in CIDP - Immunogenicity of SAR445088 - Efficacy of SAR445088 with overlapping SOC (SOC-Treated group) - Part B: - Durability of efficacy during long-term treatment with SAR445088 in CIDP - Long-term immunogenicity of SAR445088 in CIDP

NCT ID: NCT04658186 Active, not recruiting - Clinical trials for Early-stage Parkinson's Disease

A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease

ORCHESTRA
Start date: December 30, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's Disease.

NCT ID: NCT04657224 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Start date: February 25, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Part A - Dose Escalation); and the safety of the RP2Ds for this combination in different histologies/participant populations (Part B - Cohort Expansion).

NCT ID: NCT04656652 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

Start date: December 21, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

NCT ID: NCT04655976 Active, not recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy

COSTAR Lung
Start date: December 8, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

NCT ID: NCT04655469 Active, not recruiting - Clinical trials for Head and Neck Carcinoma

Personal Health Train for Radiation Oncology in India and The Netherlands

TRAIN
Start date: April 10, 2020
Phase:
Study type: Observational

The primary and general objective of this protocol as the current standard of care is to improve the quality of radiotherapy for HNC patients. This will ultimately be achieved by optimizing locoregional tumour control and overall survival and by reducing radiation-induced side effects. It will also allow the assessment of the effects of newly introduced radiation technology (e.g. proton therapy) for this particular group of patients. The clinical introduction of this standard follow-up program (SFP) will allow for a systematic and broad scale quality improvement cycle for HNC patients treated with radiotherapy.

NCT ID: NCT04655248 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

ACURATE neo2™ Post Market Clinical Follow up Study

Start date: December 16, 2020
Phase:
Study type: Observational

The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.

NCT ID: NCT04652726 Active, not recruiting - Clinical trials for Familial Hypercholesterolemia - Heterozygous

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

ORION-16
Start date: January 27, 2021
Phase: Phase 3
Study type: Interventional

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).