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NCT ID: NCT04642950 Completed - COVID-19 Clinical Trials

A Phase II/III Study of Sargramostim

Start date: December 17, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19 patients.

NCT ID: NCT04642469 Completed - Clinical trials for Carcinoma, Non- Small Cell Lung

Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

MERMAID-2
Start date: November 30, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

NCT ID: NCT04640168 Completed - COVID-19 Clinical Trials

Adaptive COVID-19 Treatment Trial 4 (ACTT-4)

Start date: December 2, 2020
Phase: Phase 3
Study type: Interventional

ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.

NCT ID: NCT04632056 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD

Start date: November 16, 2020
Phase:
Study type: Observational

This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.

NCT ID: NCT04631276 Completed - Healthy Subjects Clinical Trials

Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects

Start date: December 11, 2014
Phase: Phase 1
Study type: Interventional

To evaluate the following items by PET examination in Japanese heathy adult male subjects who received single oral administration of TS-091 in an unblinded manner. 1. Relationship between plasma concentration and H3 receptor-occupancy of TS-091 2. Time course changes in H3 receptor-occupancy of TS-091

NCT ID: NCT04630158 Completed - Chronic Ocular Pain Clinical Trials

Study of Efficacy and Safety of SAF312 Eye Drops in Subjects With Post-operative Corneal Induced Chronic Pain (CICP)

Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

The study was designed to demonstrate the safety and efficacy of two dose concentrations of SAF312 eye drops (5 mg/mL and 15 mg/mL) in subjects with CICP persisting at least for 4 months after refractive or cataract surgery and chronicity confirmed during the observational period. The study also determined the optimal dose to carry forward for further development.

NCT ID: NCT04627025 Completed - Clinical trials for Short Bowel Syndrome

Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

STARS
Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

NCT ID: NCT04626505 Completed - Inflammation Clinical Trials

Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.

RESCUE-2
Start date: October 22, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to compare the safety and effectiveness of 2 different doses of a study drug called ziltivekimab to placebo (an inactive substance) in reducing inflammation and improving some of the bad effects of inflammation on heart disease. Participants will be randomly (by chance) assigned to receive either ziltivekimab or placebo. The chance that participants will be assigned into one of the three study arms of ziltivekimab (either 15 mg or 30 mg) or placebo is the same (approximately 33%). This is a double-blind study, which means neither participants nor the study doctor will know which group the participants are in. In case of an emergency, however, the study doctor can get this information. The study drug will be injected under the skin once every 4 weeks. In this study participants will receive 3 injections of study drug. The total study duration for each participant will be approximately 6 months.

NCT ID: NCT04621136 Completed - Clinical trials for Retinopathy of Prematurity

PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity

Start date: November 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, single-arm phase I/II trial to evaluate the safety and efficacy of Rho-associated protein kinase(ROCK) inhibitor Ripasudil eye drops for preterm infants with Retinopathy of Prematurity(ROP).

NCT ID: NCT04620135 Completed - Ocular Hypertension Clinical Trials

Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Start date: November 30, 2020
Phase: Phase 3
Study type: Interventional

A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.