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NCT ID: NCT04238650 Completed - Healthy Volunteers Clinical Trials

A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers

Start date: August 2, 2019
Phase: Phase 1
Study type: Interventional

A Randomised, Double Blind, Two-Arm, Single Dose, Parallel Phase I Study To Compare the Pharmacokinetics, Safety and Immunogenicity of MB02 (a Proposed Bevacizumab Biosimilar Drug) and EU Approved Avastin® in Japanese Healthy Male Volunteers. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

NCT ID: NCT04237792 Completed - MRI Sedation Clinical Trials

Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans

Start date: February 18, 2020
Phase: Phase 4
Study type: Interventional

This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to <17 years of age undergoing MRI scans in the US and Japan.

NCT ID: NCT04237649 Terminated - Solid Tumors Clinical Trials

KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

Start date: February 20, 2020
Phase: Early Phase 1
Study type: Interventional

The primary objective of the trial was to characterize the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose (RD) for expansion of single agent KAZ954 and KAZ954 in combination with PDR001, NIR178 and NZV930.

NCT ID: NCT04235205 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Efficacy and Safety of Elobixibat in Combination With Cholestyramine for Nonalcoholic Fatty Liver Disease

Start date: January 29, 2020
Phase: Phase 2
Study type: Interventional

The objective is to evaluate the efficacy and safety of once-daily oral doses of 10 mg elobixibat in combination with 9g cholestyramine powder (cholestyramine 4g) in patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).

NCT ID: NCT04233879 Active, not recruiting - HIV-1 Infection Clinical Trials

Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

Start date: February 28, 2020
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

NCT ID: NCT04233216 Completed - HIV-1 Infection Clinical Trials

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

NCT ID: NCT04233073 Terminated - Surgery Clinical Trials

Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery

Annexa-S
Start date: June 27, 2021
Phase: Phase 2
Study type: Interventional

Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.

NCT ID: NCT04232553 Recruiting - Crohn's Disease Clinical Trials

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

VIVID-2
Start date: June 22, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

NCT ID: NCT04228367 Recruiting - Meniscus Lesion Clinical Trials

JuggerStitch Post Market Clinical Follow-up Study

Start date: September 25, 2020
Phase: N/A
Study type: Interventional

This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).

NCT ID: NCT04227600 Completed - Clinical trials for Mucopolysaccharidosis I

A Study of JR-171 in Patients With Mucopolysaccharidosis I

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

Phase I/II, open-label, multicenter, multinational (Japan, Brazil and US),designed to evaluate the safety, pharmacokinetics and explore the efficacy for the treatment of mucopolysaccharidosis type I (MPS I).