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NCT ID: NCT04050527 Completed - Clinical trials for Adult Lower Limb Spasticity

Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort

AboLiSh
Start date: December 19, 2019
Phase:
Study type: Observational

The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.

NCT ID: NCT04050436 Active, not recruiting - Clinical trials for Cutaneous Squamous Cell Carcinoma

Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

CERPASS
Start date: October 8, 2019
Phase: Phase 2
Study type: Interventional

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

NCT ID: NCT04048876 Terminated - Liver Cirrhosis Clinical Trials

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

Start date: August 14, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis. This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

NCT ID: NCT04047862 Active, not recruiting - Clinical trials for Locally Advanced and Metastatic Solid Tumors

Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors

Start date: August 26, 2019
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are : to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as Ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion cohort

NCT ID: NCT04047290 Recruiting - Neoplasms Malignant Clinical Trials

A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors

Start date: September 20, 2019
Phase: Phase 1
Study type: Interventional

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of AK112, a PD-1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumor malignancies. The study consists of a dose escalation phase (Phase 1a) to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for AK112 as a single agent, and a dose expansion phase (Phase 1b) in subjects with specific tumor types which will characterize treatment of AK112 as a single agent at the MTD or RP2D.

NCT ID: NCT04046224 Active, not recruiting - Fabry Disease Clinical Trials

Dose-Ranging Study of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects With Fabry Disease (STAAR)

Start date: July 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is the first in human treatment with ST-920, a recombinant AAV2/6 vector encoding the cDNA for human a-Gal A. The purpose of this study is to evaluate the safety and tolerability of ascending doses of ST-920. ST-920 aims to provide stable, long-term production of α-Gal A at therapeutic levels in subjects with Fabry disease. The constant production of α-Gal A in humans should, importantly, enable reduction and potentially clearance of Fabry disease substrates Gb3 and lyso-Gb3. On Day 1, patients will be infused intravenously with a single dose of ST-920 and followed for a period of 52 weeks.

NCT ID: NCT04045795 Completed - Multiple Myeloma Clinical Trials

Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Start date: August 6, 2019
Phase: Phase 1
Study type: Interventional

Primary Objectives: - To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) - To assess the safety and tolerability (including local injection site tolerability) of isatuximab using the (investigational) isatuximab injector device - To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: - To estimate absolute bioavailability of SC and IV isatuximab - To measure receptor occupancy (RO) after isatuximab SC versus IV administration - To assess efficacy of isatuximab after SC and IV administration - To assess patient expectations prior to and patient experience and satisfaction after SC administration - To evaluate potential immunogenicity of SC or IV isatuximab

NCT ID: NCT04045613 Completed - Clinical trials for Urothelial Carcinoma

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

FIDES-02
Start date: August 2, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

NCT ID: NCT04044703 Completed - Sepsis Clinical Trials

Improving Dosing of Vancomycin in Young Infants With Infections

VANCAPP
Start date: August 30, 2019
Phase: Phase 4
Study type: Interventional

Current dosing regimens for vancomycin result in many young infants not reaching the target level of vancomycin in the blood at steady state (when the blood is in equilibrium at 24-48 hours).The purpose of this study is to assess an improved method of calculating the dose of vancomycin ('model-based dosing') in young infants with infections in order for them to achieve the target vancomycin level at steady state. A dosing calculator (which will be available through a web application) will be used for the dose calculation.

NCT ID: NCT04043806 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Start date: August 9, 2019
Phase: Phase 3
Study type: Interventional

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).