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NCT ID: NCT06066515 Active, not recruiting - Obesity Clinical Trials

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

SYNCHRONIZE™-1
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have - a body mass index (BMI) of 30 kg/m² or more, or - a BMI of 27 kg/m² or more and at least one health problem related to their weight. People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.

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.

NCT ID: NCT05989672 Active, not recruiting - Herpes Simplex Clinical Trials

A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years

TH HSV REC-004
Start date: August 8, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2 seronegative ethnic Japanese adults aged 18-40 years.

NCT ID: NCT05962008 Active, not recruiting - Clinical trials for Healthy Japanese Subjects

Effects of Consumption of Phosphatidylserine on the Cognitive Function

Start date: July 20, 2023
Phase: N/A
Study type: Interventional

The main objective of this trial is to verify the effects of consumption of phosphatidylserine for 12 weeks on the cognitive function in healthy Japanese subjects.

NCT ID: NCT05932641 Active, not recruiting - Clinical trials for COVID-19, SARS-CoV-2

Study of AZD3152 Intramuscular Injection or Intravenous Infusion in Healthy Japanese Adult Participants

Start date: July 31, 2023
Phase: Phase 1
Study type: Interventional

AZD3152 is being evaluated for administration to prevent COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD3152 as well as relevant data on the PK, PD (as the neutralising responses against SARS-CoV-2) profile and the generation of ADA to AZD3152.

NCT ID: NCT05931445 Active, not recruiting - Breast Cancer Clinical Trials

Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer

Start date: January 26, 2021
Phase: N/A
Study type: Interventional

This is a multicenter, open-label, randomized, controlled study to test the hypothesis that ePRO monitoring added to usual care helps prolong OS or maintain and improve HRQoL in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy.

NCT ID: NCT05931380 Active, not recruiting - Obesity Clinical Trials

A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease

ATTAIN-J
Start date: July 31, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.

NCT ID: NCT05923112 Active, not recruiting - Clinical trials for Acute Lymphocytic Leukemia

BESPONSA Injection 1 mg Special Investigation

Start date: July 2, 2018
Phase:
Study type: Observational

The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia. Registration criteria for this study is all patients who starting BESPONSA from its launch to the market to April 30, 2020. All patients in this study will receive BESPONSA according to the prescriptions. Patients will be followed up as follow. - 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA. - Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.