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NCT ID: NCT06298643 Active, not recruiting - Clinical trials for Lower-risk Myelodysplastic Syndromes

Real-World Practice Patterns and Outcomes of Lower-Risk Myelodysplastic Syndrome Patients in Japan

Start date: December 22, 2023
Phase:
Study type: Observational

The purpose of this study is to describe the treatment patterns, clinical outcomes, healthcare resource utilization (HCRU) and medical costs of lower-risk myelodysplastic syndromes patients in Japan.

NCT ID: NCT06212089 Active, not recruiting - Parkinson Disease Clinical Trials

Phase II Clinical Study of TR-012001 in Japanese Patients With Parkinson's Disease

Start date: September 28, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study to evaluate the safety and pharmacokinetics of TR-012001 in patients with Parkinson's disease when TR-012001 or placebo is administered.

NCT ID: NCT06151561 Active, not recruiting - Clinical trials for Moderate to Severe Glabellar Lines

Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines

Start date: January 5, 2024
Phase: Phase 1
Study type: Interventional

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe GL in Japanese participants. AGN-151586 is an investigational product being developed for the treatment of GL. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. The duration of the study will be approximately 6 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT06149104 Active, not recruiting - Heart Failure Clinical Trials

A Safety Study of Sacubitril/Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study

Start date: December 4, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this open-label study is to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible Japanese patients who completed CLCZ696B2319E1 study until marketed product of pediatric formulation, film-coated granules in capsule, is available in Japan.

NCT ID: NCT06106568 Active, not recruiting - Liver Metastases Clinical Trials

An Observational Study to Learn More About the Impact of Gadoxetate Sodium-Enhanced Magnetic Resonance Imaging (EOB-MRI) When Used to Diagnose the Spread of Cancer From the Pancreas to the Liver in Japanese People Under Real-World Conditions

Start date: November 20, 2023
Phase:
Study type: Observational

This is an observational study in which data from people with cancer that has spread from the pancreas to the liver are collected and studied. These adults will include people who already received their usual treatment and who have had a certain type of imaging scan before the diagnosis of pancreatic cancer. Metastatic pancreatic cancer is a cancer that starts in the pancreas, a gland that helps to digest food, and has spread to other parts of the body. Pancreatic cancer most commonly spreads to the liver (called liver metastasis). Gadoxetate sodium-enhanced magnetic resonance imaging (EOB-MRI) is a type of imaging technique that uses a specific dye called gadoxetate sodium to produce clearer images of the liver. Participants with pancreatic cancer can be treated with surgery only if their cancer has not spread to other parts of the body. Therefore, it is important to find out if the cancer has spread to other parts of the body before performing surgery. To do this, different imaging scans such as exploratory laparoscopy and CE-CT are used. However, these tests have certain limitations, such as complicated procedures or, in some cases inaccurate results. Some studies suggest that performing EOB-MRI along with a regular CT scan may improve the chances of finding out if pancreatic cancer has spread to the liver. This imaging technique is especially helpful in detecting smaller tumors that may be missed in other types of scan. However, more information is needed to better understand the impact of EOB-MRI in Japanese people under real-world conditions. The main purpose of this study is to learn more about how using EOB-MRI helps in deciding the treatment options, how well the participants do, and how much does the use of medical care facilities costs. The main information that researchers will collect in this study: participant characteristics, including age, sex, whether they smoke or not, how well they can manage daily tasks, any other health problems they have, how advanced their cancer is, and if they have undergone laparoscopy the length of time: from the date of diagnosis of pancreatic cancer until a participant dies (called overall survival) from the date of first treatment for pancreatic cancer until the cancer spreads of other organs from the date of diagnosis of pancreatic cancer to starting the first treatment from the date of first treatment for pancreatic cancer to starting the second treatment option treatments that the participants have received, including anti-cancer drugs, radiation, and surgery the number of hospital visits, use of healthcare facilities, and related costs. The information in this study will be grouped based on the participants who had an EOB-MRI and those who had non EOB-MRI. The data will come from the participants' information stored in a database called Medical Data Vision (MDV) in Japan. Data collected will be from January 2011 to October 2022. Researchers will track individual patients' data for at least 1 year, until death, until there is no health record in the MDV for 2 months after treatment starts, or until the end of study. In this study, only available data from health records are collected. No visits or tests are required as part of this study.

NCT ID: NCT06093542 Active, not recruiting - Heathy Participants Clinical Trials

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.

Start date: October 25, 2023
Phase: Phase 1
Study type: Interventional

The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.

NCT ID: NCT06081829 Active, not recruiting - Clinical trials for Cholangiocarcinoma Non-resectable

A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Start date: October 10, 2023
Phase: Phase 2
Study type: Interventional

This study will enroll participants with nonresectable or metastatic cholangiocarcinoma with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have previously received at least 1, but no more than 2, prior regimens for advanced disease. All participants will receive ivosidenib daily throughout multiple 28 day cycles. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), every other week during Cycles 2 and 3, and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an end of treatment and a post-treatment follow-up visit, and participants will be followed to assess overall survival. Study visits may include a tumor assessment, physical exam, electrocardiogram (ECG), blood and urine analysis, and questionnaires.

NCT ID: NCT06042049 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab

JUBILUS
Start date: July 27, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months. Study details include - The study duration is approximately 21 months with a 2-month enrollment period. - Study intervention is 2 doses administered 5- 6 months apart. - The study has 5 or 6 site visits and several telephone contacts with a 2 or 4 week interval

NCT ID: NCT06039020 Active, not recruiting - Aplastic Anemia Clinical Trials

ATGAM General Investigation

Start date: February 21, 2024
Phase:
Study type: Observational

The objective of this study is to confirm the safety of ATGAM in patients with moderate to severe aplastic anemia under the actual use in Japan. The registration criteria is patients with moderate to severe aplastic anemia who receive ATGAM. The observation period is 24 weeks (6 months) from the start of administration (Day 1). However, in cases where treatment has been completed or discontinued less than 24 weeks after the start of administration, observation is continued until completion (discontinuation) of treatment.

NCT ID: NCT06007781 Active, not recruiting - Gastroenteritis Clinical Trials

Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants

Start date: August 18, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age (-14/+14 days) at first trial vaccine administration. In this protocol, because the trial is blinded, trial vaccine refers to both the investigational vaccine (HIL-214) and placebo.