Clinical Trials Logo

Filter by:
NCT ID: NCT04673357 Active, not recruiting - Crohn Disease Clinical Trials

A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

UNITI Jr
Start date: April 6, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active Crohn's disease.

NCT ID: NCT04671472 Completed - GNE Myopathy Clinical Trials

Efficacy Confirmation Study of NPC-09

Start date: February 8, 2021
Phase: Phase 3
Study type: Interventional

GNE myopathy is a distal myopathy that is thought to be caused by a mutation in the GNE gene that encodes an enzyme in the biosynthetic process of aceneuramic acid (typical sialic acid). The investigators will examine the efficacy and safety of aceneuramic acid (SA-ER tablets) 6g daily for 48 weeks in patients with GNE myopathy in a placebo-controlled, double-blind, controlled trial.

NCT ID: NCT04668157 Completed - Hypertension Clinical Trials

A Study of TAK-536 in Children From 2 to Less Than 6 Years Old With High Blood Pressure

Start date: May 17, 2021
Phase: Phase 3
Study type: Interventional

The main aim of this study is to check the safety of TAK-536. This study will take place in Japan. At the first visit, the study doctor will check if each child can take part. For those who can take part, each participant will have a check-up by the study doctor. This might take 2 weeks or longer. After this, parents or the caregivers of each participant will be given sachets that contain granules of TAK-536 to give to that participant. The participants will take the TAK-536 granules once a day for 52 weeks. After treatment has finished, participants will visit the study clinic for a final check-up.

NCT ID: NCT04667104 Completed - Clinical trials for Hepatitis B, Chronic

A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

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

The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 + nucleos[t]ide analog [NA] and pegylated interferon alpha-2a [PegIFN-alpha2a]).

NCT ID: NCT04666298 Completed - Clinical trials for Hypercholesterolemia

Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

ORION-15
Start date: January 29, 2021
Phase: Phase 2
Study type: Interventional

This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).

NCT ID: NCT04666038 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

BRUIN CLL-321
Start date: March 9, 2021
Phase: Phase 3
Study type: Interventional

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

NCT ID: NCT04665700 Completed - Healthy Clinical Trials

A Study in Healthy Japanese Men to Test How Well Different Doses of BI 764198 Are Tolerated

Start date: February 6, 2021
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single dose and multiple rising doses per day over 14 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing.

NCT ID: NCT04665050 Completed - Clinical trials for Pneumococcal Infection

Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

Start date: February 4, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.

NCT ID: NCT04662710 Active, not recruiting - Clinical trials for Advanced/Metastatic Gastroesophageal Adenocarcinoma

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

LEAP-015
Start date: December 30, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.

NCT ID: NCT04662255 Active, not recruiting - Clinical trials for Lymphoma, Mantle-Cell

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

BRUIN-MCL-321
Start date: April 8, 2021
Phase: Phase 3
Study type: Interventional

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.