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NCT ID: NCT05696080 Completed - Clinical trials for Pneumococcal Infection

Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

STRIDE-8
Start date: February 13, 2023
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination. within each vaccination group separately.

NCT ID: NCT05687916 Completed - Narcolepsy Type 2 Clinical Trials

A Study of TAK-861 in Participants With Narcolepsy Type 2

Start date: January 9, 2023
Phase: Phase 2
Study type: Interventional

The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

NCT ID: NCT05687903 Completed - Narcolepsy Type 1 Clinical Trials

A Study of TAK-861 in Participants With Narcolepsy Type 1

Start date: January 9, 2023
Phase: Phase 2
Study type: Interventional

The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.

NCT ID: NCT05683340 Completed - Clinical trials for Hyper-low-density Lipoprotein (LDL) Cholesterolemia

A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

Start date: February 13, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm the superiority of ETC-1002 after 12 weeks of administration at 180 mg/day to placebo in patients with hyper-LDL cholesterolemia who have inadequate control of low-density lipoprotein cholesterol (LDL C).

NCT ID: NCT05683327 Completed - Clinical trials for Healthy Japanese Subjects

The Effect of Oral Hyaluronic Acid (UltraHA®) on the Knee Function

Start date: January 6, 2023
Phase: N/A
Study type: Interventional

This clinical trial aims to clarify the effect of UltraHA® on knee joint conditions.

NCT ID: NCT05681715 Completed - Clinical trials for Generalized Myasthenia Gravis

A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

Start date: April 17, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.

NCT ID: NCT05650164 Completed - Clinical trials for Renal Cell Carcinoma

Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)

Start date: January 25, 2023
Phase:
Study type: Observational

This study is a multicenter, non-interventional, retrospective, medical chart review of patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 17 October 2022. All decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site.

NCT ID: NCT05633992 Completed - Clinical trials for Pneumococcal Disease

Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)

Start date: January 10, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).

NCT ID: NCT05624944 Completed - Clinical trials for Patients With Mild or Moderate Hepatic Impairment

A Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment

Start date: December 26, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment

NCT ID: NCT05621447 Completed - Clinical trials for Healthy Male Subjects

A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects

Start date: September 7, 2022
Phase: Phase 1
Study type: Interventional

To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-303 following oral single dose