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NCT ID: NCT04677530 Completed - Healthy Clinical Trials

A Study of JNJ-40411813 in Healthy Japanese Male Participants

Start date: January 29, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult male participants.

NCT ID: NCT04676724 Completed - Hepatitis B Clinical Trials

Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)

B-Together
Start date: January 28, 2021
Phase: Phase 2
Study type: Interventional

This study is intended to evaluate if 12 or 24 weeks of treatment with GSK3228836 followed by up to 24 weeks of pegylated interferon (PegIFN) can increase the rate of hepatitis B virus surface antigen (HBsAg) loss in participants on stable nucleos(t)ide analogue (NA) therapy, and whether virologic response can be sustained once PegIFN treatment is discontinued. Participants will be randomized to receive GSK3228836 for 12 or 24 weeks followed by up to 24 weeks of PegIFN.

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: 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: NCT04660539 Completed - Clinical trials for Neuromyelitis Optica Spectrum Disorder

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

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

This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.

NCT ID: NCT04657497 Completed - Clinical trials for SARS-CoV-2 Infection (COVID-19)

A Study of FOY-305 in Patients With SARS-Cov-2 Infection (COVID-19)

Start date: November 9, 2020
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of FOY-305 in patients with SARS-CoV-2 infection (COVID-19) in a placebo-controlled, multicenter, double-blind, randomized, parallel-group comparative study.