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NCT ID: NCT03874013 Completed - Clinical trials for Growth Hormone Deficiency

Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency

Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

Treatment of children with growth failure due to growth hormone deficiency (GHD). Primary • To evaluate the efficacy and safety of weekly MOD-4023 administration compared to daily Genotropin® administration in Japanese pre-pubertal children with GHD. Secondary • To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of three different doses of MOD-4023 in Japanese pre-pubertal children with GHD.

NCT ID: NCT03873116 Completed - Clinical trials for Hereditary Angioedema, HAE

Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan

APeX-J
Start date: February 28, 2019
Phase: Phase 3
Study type: Interventional

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE who live in Japan.

NCT ID: NCT03870087 Completed - Clinical trials for Coronary Artery Disease

PRECISION GRX Post-Market Study - Japan

Start date: April 12, 2019
Phase:
Study type: Observational [Patient Registry]

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures in the first 231 patients treated with the CorPath device in Japan.

NCT ID: NCT03868267 Recruiting - Clinical trials for Functional Dyspepsia

Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting

Start date: May 9, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this prospective cohort study is to compare upper GI symptoms and endoscopy findings in Canada with Japan and Iran, and correlate this with the upper GI microbiome. The investigators plan to recruit 500 new patients referred for upper GI endoscopy in Canada (McMaster University) and 500 in Japan (Tohoku University Hospital) and 500 from Iran (Tehran University of Medical Sciences). Written consent will be obtained from all participants. Patients will complete three symptom questionnaires and a demographic one before endoscopy. Then saliva collection device will be applied for collecting saliva and microbiota from the oral cavity. Esophagogastroduodenoscopy (EGD) will be performed thereafter and brushing of the esophagus, stomach, and the duodenum will be done using a sterile sheathed brush (one for each site) to sample collect gut microbiota and gastric biopsies will be done for assessing H.pylori status. In addition, a group of these patients will undergo measurement of nitrate reductase activity (NRA) in their oral cavity. This will be done on twenty erosive gastro-esophageal reflux disease (GERD) patients, twenty non-erosive GERD patients, and twenty patients without any endoscopic or clinical GERD. This latter part of the study will be done at the Canadian and Iranian sites only. Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center. For specific substudies analysis of the mycome will also be carried out.

NCT ID: NCT03867084 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)

Start date: May 28, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).

NCT ID: NCT03864484 Recruiting - Clinical trials for Post-stroke Depression

iPad Application-based Intervention for Post-stroke Depression

Start date: May 7, 2019
Phase: N/A
Study type: Interventional

We plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an iPad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone. The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.

NCT ID: NCT03864458 Completed - Hyperphosphatemia Clinical Trials

Dose-finding Study of KHK7791 in Hyperphosphatemia Patients

Start date: April 15, 2019
Phase: Phase 2
Study type: Interventional

To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.

NCT ID: NCT03864445 Completed - Hyperphosphatemia Clinical Trials

Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients

Start date: April 29, 2019
Phase: Phase 2
Study type: Interventional

To evaluate the effect and safety of KHK7791 in combination with phosphate binders to treat Hyperphosphatemia in ptatients on HD.

NCT ID: NCT03864185 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies

RECIPE
Start date: March 28, 2019
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of rituximab (genetical recombination) intravenously administered to CIDP patients with positive or negative IgG4 autoantibody.

NCT ID: NCT03861273 Active, not recruiting - Hemophilia B Clinical Trials

A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

BENEGENE-2
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objective of the study will evaluate the annualized bleeding rate [ABR] for participants treated with gene therapy versus standard of care (SOC) therapy (FIX prophylaxis replacement regimen).