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NCT ID: NCT02639247 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

POLARIS-4
Start date: December 23, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

NCT ID: NCT02634008 Completed - Hepatitis C, Acute Clinical Trials

Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P

TARGET3D
Start date: June 2016
Phase: Phase 3
Study type: Interventional

An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.

NCT ID: NCT02631707 Completed - Obesity, Morbid Clinical Trials

The Effect of High Protein Diets on Weight Loss and Lean Muscle Mass in Patients Awaiting Bariatric Surgery

Start date: May 2015
Phase: N/A
Study type: Interventional

All patients in CMDHB eligible for bariatric surgery are given a weight loss goal prior to surgery. It is unknown what the most effective diet is to lose weight, while still preserving muscle mass. The diet must also be acceptable and adhered to by patients. The aim of this study is to find out if a diet that is higher in protein and lower in carbohydrate than the standard Ministry of Health guidelines will have a greater effect on weight loss, preservation of lean muscle mass, surgical recovery score, adherence and acceptability.

NCT ID: NCT02631096 Completed - Clinical trials for Hepatitis B, Chronic

Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy

Start date: December 2015
Phase: Phase 2
Study type: Interventional

The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of intravenous ARB-001467

NCT ID: NCT02625909 Completed - Hepatitis C Clinical Trials

Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection.

REACT
Start date: March 9, 2017
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine if treatment for recently acquired hepatitis C infection (with or without HIV coinfection) can be shortened when treating with the interferon-free therapy sofosbuvir/velpatasvir (SOF/VEL). SOF/VEL is a new treatment for hepatitis C called direct acting antiviral which targets the hepatitis C virus replication cycle and has been shown in phase II studies in chronic HCV to be highly effective (SVR12 >95%) when given for 12 weeks. Data has shown that treatment can be shortened when treating recently acquired HCV with interferon containing treatments. It is not known whether treatment with SOF/VEL can be shortened. This study aims to find out if treatment for 6 weeks with open-label SOF/VEL is equivalent to treatment for 12 weeks with SOF/VEL in participants with recently acquired hepatitis C infection. The project is a randomised study where both participants and investigators would not find out the treatment duration of the participants until week 6 of treatment.

NCT ID: NCT02624947 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization

Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia through the first 90 days of life in infants.

NCT ID: NCT02623322 Completed - Influenza A Clinical Trials

A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy Adults

Start date: October 12, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.

NCT ID: NCT02622321 Completed - Hemophilia A Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors

HAVEN 1
Start date: November 18, 2015
Phase: Phase 3
Study type: Interventional

This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of prophylactic emicizumab treatment in participants previously treated with episodic or prophylactic bypassing agents. Episodic bypassing agent participants will be randomized in a 2:1 fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will be stratified across Arms A and B according to the number of bleeds they experienced over the last 24 weeks prior to study entry (less than [<] 9 or greater than or equal to [>/=] 9 bleeds); Arm B participants will have the opportunity to switch to emicizumab prophylaxis after at least 24 weeks on-study. Prophylactic bypassing agent participants will switch to emicizumab prophylaxis (Arm C) from the start of the trial; enrollment will be extended for 24 weeks after the last participant has enrolled in Arms A or B or until approximately 50 participants have enrolled in Arm C, whichever occurs first. Episodic bypassing agent participants who previously participated in the non-interventional study BH29768 (NCT02476942) who were unable to enroll in Arms A or B, or participants on prophylactic bypassing agents who were unable to enroll in Arm C, prior to their closure will have the opportunity to enroll in Arm D. Like participants in Arms A and C, Arm D participants will receive emicizumab prophylaxis from the start of the trial. All participants will continue to receive episodic bypassing agent therapy to treat breakthrough bleeds, preferably with recombinant activated factor VII (rFVIIa).

NCT ID: NCT02617784 Completed - Clinical trials for End Stage Renal Disease

A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

Start date: October 2001
Phase: Phase 1
Study type: Interventional

This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.

NCT ID: NCT02610361 Completed - Solid Tumors Clinical Trials

Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors

Start date: November 20, 2013
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-283 in patients with solid tumours.