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NCT ID: NCT04819100 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

LIBRETTO-432
Start date: December 20, 2021
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

NCT ID: NCT04818983 Completed - Clinical trials for Non-small Cell Lung Cancer

The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

Start date: April 7, 2021
Phase:
Study type: Observational

This study is implemented in association with the study "J-TAIL-2" ; prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.

NCT ID: NCT04818840 Recruiting - Arthroplasty Clinical Trials

Evaluate the Performance of JOURNEY II CR in TKA Populations

JIICRTKA
Start date: March 3, 2022
Phase:
Study type: Observational

Background: The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II CR Total Knee System Objectives: Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA Research participants / locations: A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.

NCT ID: NCT04818671 Active, not recruiting - Clinical trials for Generalized Myasthenia Gravis

Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

ADAPTSC+
Start date: April 26, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

NCT ID: NCT04818398 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva

Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects

Start date: April 1, 2021
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.

NCT ID: NCT04817618 Recruiting - C3G Clinical Trials

Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

APPEAR-C3G
Start date: July 28, 2021
Phase: Phase 3
Study type: Interventional

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

NCT ID: NCT04816214 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study Evaluating Efficacy and Safety of Capmatinib in Combination With Osimertinib in Adult Subjects With Non-small Cell Lung Cancers as Second Line Therapy

GEOMETRY-E
Start date: September 22, 2021
Phase: Phase 3
Study type: Interventional

This study aimed to evaluate the anticancer activity of capmatinib in combination with osimertinib compared to platinum-pemetrexed based doublet chemotherapy as second line treatment in patients with advanced or metastatic non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation, T790M negative, mesenchymal-to-epithelial transition factor (MET) amplified who progressed following EGFR tyrosine kinase inhibitors (TKIs).

NCT ID: NCT04815031 Completed - COVID-19 Clinical Trials

Drug Use Investigation of COMIRNATY Intramuscular Injection

Start date: March 20, 2021
Phase:
Study type: Observational

Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.

NCT ID: NCT04814771 Completed - Clinical trials for Healthy Male Subjects

Mass Balance Study of TS-142 in Healthy Adult Subjects.

Start date: April 19, 2021
Phase: Phase 1
Study type: Interventional

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-142 after single oral dose of [14C] TS-142 in Japanese healthy male subjects. To assess the safety of single oral dose of [14C] TS-142 in Japanese healthy male subjects.

NCT ID: NCT04813263 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia

Start date: May 28, 2021
Phase:
Study type: Observational

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice. Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan. Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets. There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.