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NCT ID: NCT04346108 Completed - Clinical trials for Primary Immunodeficiency Diseases (PID)

A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)

Start date: August 11, 2020
Phase: Phase 3
Study type: Interventional

In this study, Japanese participants with primary immunodeficiency diseases were treated with Immune Globulin Subcutaneous (Human), 20% solution, (IGSC, 20%). This study will be in 3 parts: Part 1: Infusions with Immunoglobulin Intravenous (IGIV) every 3 or 4 weeks for 13 weeks. Part 2: Participants will switch to weekly subcutaneous infusions with IGSC, 20% for 24 weeks. Part 3: A subset will receive biweekly subcutaneous infusions with IGSC, 20% for 12 weeks. The main aim of the study is to assess base levels of Immunoglobulin globulin G (IgG) levels in the blood of the participants after weekly and biweekly treatment with IGSC, 20% (in Parts 2 and 3 of the study). Their PID will be treated by their doctor according to their doctor's usual clinical practice.

NCT ID: NCT04345627 Recruiting - Arrhythmia, Cardiac Clinical Trials

Japanese Lead Extraction Registry

J-LEX
Start date: July 1, 2018
Phase:
Study type: Observational [Patient Registry]

Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The acute success rate at discharge and the complications associated with transvenous lead extraction will be collected. J-LEX registry will provide a reliable information on indications, methods, the success rate, complications and the prognosis at 30 days prognosis.

NCT ID: NCT04345471 Completed - Clinical trials for Major Depressive Disorder

A Study of MD-120 in Patients With Depression

Start date: May 18, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with depression.

NCT ID: NCT04342325 Completed - Clinical trials for Glomerulonephritis , IGA

The Clinical Trial of ADR-001 for IgA Nephropathy

Start date: June 15, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and the tolerability of ADR-001 in Immunoglobulin A (IgA) Nephropathy patients. In addition, the investigators will evaluate the efficacy of ADR-001 for IgA Nephropathy patients.

NCT ID: NCT04342273 Completed - Parkinson's Disease Clinical Trials

A Through QT/QTc Study of KW-6356

Start date: March 31, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effects of multiple therapeutic and supratherapeutic doses of KW-6356 on the QT interval corrected for heart rate in Japanese healthy adults.

NCT ID: NCT04340193 Terminated - Clinical trials for Cancer, Hepatocellular

A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer

CheckMate 74W
Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.

NCT ID: NCT04340115 Recruiting - Clinical trials for Rheumatoid Arthritis (RA)

Study To Assess Frequency Of Serious Infections In Clinical Practice In Japan For Adult Participants With Rheumatoid Arthritis Receiving Oral RINVOQ Tablets

Start date: April 24, 2020
Phase:
Study type: Observational

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. The purpose of this study is to observe the incidence of serious infections, regardless of their relationship to RINVOQ, in Japanese daily practice. RINVOQ is an approved drug for the treatment of adults with moderately to severely active RA. This study evaluates medical records from institutions participating in the study to identify any adverse events (untoward medical occurrence), and reasons for discontinuation of RINVOQ in participants taking the study drug. A target of 1000 Japanese participants' data will be observed for 3 years. Participants will receive RINVOQ per their physicians' usual prescription. Individual data will be collected for three years. No additional study-related tests will be conducted during routine clinic visits. Only data which are routinely collected during clinic visits will be utilized for this study.

NCT ID: NCT04339413 Terminated - Alzheimer Disease Clinical Trials

A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

Start date: May 22, 2020
Phase: Phase 3
Study type: Interventional

The main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of studies WN25203 or WN28745 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit.

NCT ID: NCT04338399 Active, not recruiting - Clinical trials for Head and Neck Cancer

The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC

BURAN
Start date: December 12, 2020
Phase: Phase 3
Study type: Interventional

The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

NCT ID: NCT04338269 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment

CONTACT-03
Start date: July 28, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.