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NCT ID: NCT04696952 Completed - Healthy Subjects Clinical Trials

A Study to Evaluate Next Day Effects of TS-142 on Driving Performance in Healthy Subjects

Start date: January 16, 2021
Phase: Phase 1
Study type: Interventional

A clinical study to evaluate the residual effects of TS-142 on driving performance in healthy and elderly subjects.

NCT ID: NCT04696809 Active, not recruiting - Clinical trials for Hematologic Malignancies

A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Start date: February 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part.

NCT ID: NCT04696328 Recruiting - Myocardial Ischemia Clinical Trials

Clinical Trial of Human (Allogeneic) iPS Cell-derived Cardiomyocytes Sheet for Ischemic Cardiomyopathy

Start date: December 2, 2019
Phase: Phase 1
Study type: Interventional

Targeting patients with severe ischemic cardiomyopathy, the purpose of this study is as follows: to confirm short-term efficacy by observing changes and transitions in cardiac function and clinical symptoms compared with each patient's baseline (before and after comparison) by human iPS cell-derived cardiomyocyte sheet transplantation, and to evaluate the safety and tolerability including the combined use of immunosuppressants.

NCT ID: NCT04696055 Completed - Clinical trials for Hepatocellular Carcinoma

Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors

Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people diagnosed with liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab. There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC. During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.

NCT ID: NCT04695522 Recruiting - D017202 Clinical Trials

ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery

Start date: November 27, 2019
Phase: Phase 1
Study type: Interventional

Ischemic cardiomyopathy undergoing coronary artery bypass surgery

NCT ID: NCT04691700 Recruiting - Heart Failure Clinical Trials

GOREISAN for Heart Failure (GOREISAN-HF) Trial

GOREISAN-HF
Start date: January 19, 2021
Phase: Phase 4
Study type: Interventional

The objective of the GOREISAN-HF trial is to assess the effect of the administration of Goreisan (TJ-17) plus standard therapy compared to standard therapy alone on the improvement rate of cardiac edema and clinical outcomes in worsening congestive heart failure with volume overload.

NCT ID: NCT04689594 Terminated - Clinical trials for Superficial Esophageal Cancer

A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the Steroid Administration Risk Group

Start date: February 4, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal wound site after extensive ESD for superficial esophageal cancer in the steroid administration risk group.

NCT ID: NCT04688775 Completed - Clinical trials for Cluster Headache, Episodic

Eptinezumab in Participants With Episodic Cluster Headache

ALLEVIATE
Start date: December 23, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

NCT ID: NCT04688034 Completed - Liver Cirrhosis Clinical Trials

Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV With Hemophilia.

Start date: March 15, 2021
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.

NCT ID: NCT04687137 Completed - Clinical trials for Hereditary Angioedema

Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema

Start date: February 10, 2021
Phase: Phase 3
Study type: Interventional

The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. Lanadelumab, also known as TAK-743, is a medicine to help prevent hereditary angioedema attacks. Lanadelumab is not yet licensed for use in Japan. The main aim of this study is to allow Japanese teenagers and adults with type I or type II hereditary angioedema to be treated with lanadelumab, through the expanded access program in Japan. Participants can either have taken part in the previous study SHP643-302 or can be new participants. Participants just completing study SHP643-302 who reach the criteria can automatically take part in this study. However, for new participants, the study doctor will check who can take part at the first study visit. For those who can take part, new participants will receive injections of lanadelumab just under the skin. Eventually, after training, some of these will be able to inject themselves with lanadelumab in the same way. Participants who injected themselves with lanadelumab in study SHP643-302 can continue to do so during this study. The study doctors will decide if each participant will be treated with lanadelumab every 2 weeks or every 4 weeks. Treatment with lanadelumab will continue until lanadelumab is commercially available in Japan or the sponsor (Takeda) stops the study. Participants can visit the clinic during treatment if needed. If treatment continues after 6 months, participants will visit the clinic every 12 weeks for a check-up. This will include noting any hereditary angioedema attacks and side effects from the treatment. After 7 months of treatment, the study staff will check-up with each participant every 2 weeks by telephone. After treatment has finished, participants will visit the clinic for a final-check-up 4 weeks later.