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NCT ID: NCT04057937 Completed - Clinical trials for Palmoplantaris Pustulosis

A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis

Start date: October 16, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations. The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.

NCT ID: NCT04057131 Completed - Clinical trials for Hereditary Angioedema (HAE)

FIRAZYR General Drug Use-Results Survey (Japan)

Start date: May 9, 2019
Phase:
Study type: Observational

The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).

NCT ID: NCT04056611 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)

FREESIA
Start date: December 26, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.

NCT ID: NCT04053634 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations

RESOLUTE
Start date: August 26, 2019
Phase: Phase 3
Study type: Interventional

Phase 3 study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils (≥300/μL). Eligible patients must have a history of ≥2 moderate and/or severe COPD exacerbations in the previous year despite receiving triple (ICS/LABA/LAMA) background therapy for at least 3 months and ICS-based dual inhaled treatment for the remainder of the year. Eligible patients must also have an elevated blood eosinophil count. The treatment period will be of variable duration and will continue until the last patient has the opportunity to complete a minimum of 56 weeks, at which point all patients will complete the study. The primary endpoint will be analyzed at Week 56.

NCT ID: NCT04052243 Recruiting - Clinical trials for Chronic Thromboembolic Pulmonary Hypertension

Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH

EXPERT-BPA
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right heart failure. Medical therapy and balloon angioplasty (BPA) are effective treatment alternatives in lowering pulmonary pressures and increasing pulmonary flow. The aim of this study is to assess the hemodynamic effects of BPA or medical therapy on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance.

NCT ID: NCT04052113 Completed - Urologic Neoplasms Clinical Trials

Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer

YODO
Start date: October 25, 2019
Phase:
Study type: Observational

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected to assay PD-L1 expression and next generation sequencer (NGS) assay for tumor mutation burden (TMB).

NCT ID: NCT04049825 Active, not recruiting - Clinical trials for Relapsed or Refractory Diffuse Large B-cell Lymphoma

A Phase 1 Trial of OPB-111077 in Combination With Bendamustine and Rituximab in Patients With r/r DLBCL

Start date: November 22, 2019
Phase: Phase 1
Study type: Interventional

To investigate the tolerability and safety of OPB-111077 in combination with bendamustine and rituximab in patients with r/r DLBCL.

NCT ID: NCT04048876 Terminated - Liver Cirrhosis Clinical Trials

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

Start date: August 14, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis. This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

NCT ID: NCT04048343 Completed - Severe Asthma Clinical Trials

Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma

NOZOMI
Start date: June 10, 2019
Phase: Phase 3
Study type: Interventional

This is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with inadequately controlled severe asthma.

NCT ID: NCT04047160 Completed - Clinical trials for Liver Cirrhosis, Biliary

Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)

Start date: August 29, 2019
Phase: Phase 1
Study type: Interventional

To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.