There are about 7997 clinical studies being (or have been) conducted in Japan. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension sub study is to extend the observation period of the main study and to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative females who complete mRNA-1647-P301 main study and to assess for CMV seroconversion in CMV-seronegative participants who did not seroconvert during mRNA-1647-P301 main study. No interventional vaccine will be administered in the extension study.
To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan. The present study aims to collect information on adverse drug reactions or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine.
To investigate the efficacy and safety of 4 mg/day of WY-8678 (guanabenz acetate) and 8 mg/day of WY-8678 (guanabenz acetate) in patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH patients) with hypertension
The main aim of the study is to check for side effects from TAK-771, and to check how well TAK-771 controls symptoms in Japanese participants with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) The participants will be treated with TAK-771 for 45 months as a maximum. There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug (every 2, 3, or 4 weeks).
The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2). The secondary objective of this study is to evaluate the pharmacokinetic(s) (PK) of DRF metabolites (monomethyl fumarate [MMF] and 2-hydroxyethyl succinimide [HES]) following multiple doses of DRF in a subset of adult East Asian participants with RMS (Part 1).
Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The researchers are finding ways to switch the T-cells back on. Early studies have shown that ASP1570 can switch T-cells back on to attack tumors. This study will provide more information on this potential new treatment in adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. People will either be treated with ASP1570 by itself, or together with another medicine called pembrolizumab. This study will be in 2 parts. In Part 1, the best dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570 by itself or with pembrolizumab. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 dose of pembrolizumab. After taking the lowest dose of ASP1570, the first group will be checked for medical problems. The next group can only take the higher dose of ASP1570 if the first group on the lowest dose had no major medical problems. This will continue in the same way for each group. This means each group will take the next highest dose of ASP1570 as long as the previous group did not have any major medical problems. Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle. People taking part in Japan will stay in hospital for up to 21 days during the first treatment cycle only. People will continue with more treatment cycles on the same dose unless they have major medical problems, their cancer gets worse or the study doctor decides that person should stop treatment. People who are also receiving treatment with pembrolizumab will be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). In Part 2, different small groups of people with advanced solid tumors will take the best dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that people took in Part 1 without getting major medical problems. Some groups of people will have specific advanced tumors. These include tumors from metastatic melanoma or non-small cell lung cancer (NSCLC for short). Other groups will have solid tumors that showed a response in Part 1. Again, each group will take tablets of ASP1570 once or twice every day in a 21-day cycle. Only people with NSCLC will also be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). All groups will continue with more treatment cycles with ASP1570 by itself or with pembrolizumab, unless they have major medical problems, their cancer gets worse or the study doctor decides that person should stop treatment. After treatment with ASP1570, people in the study will visit their clinic 45 days after their last dose of ASP1570. People who were treated with ASP1570 and pembrolizumab will visit their clinic either 45 days after their last dose of ASP1570 or 30 days after their last dose of pembrolizumab. It will depend on which treatment was the last one they had. Then, the study clinic will contact each person in the study at least every 12 weeks until the end of the study or if they decide to leave the study.
The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.
This is a phase 1/2, open-label, multi-centre study of surufatinib in patients with unresectable, locally advanced, or recurrent nonhematologic malignancies who do not respond or are intolerant to standard of care.
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.