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NCT ID: NCT03687255 Completed - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.

NCT ID: NCT03669588 Completed - Clinical trials for Generalized Myasthenia Gravis

An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

ADAPT
Start date: August 22, 2018
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

NCT ID: NCT03654274 Completed - Endometriosis Clinical Trials

SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

Start date: May 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).

NCT ID: NCT03650413 Terminated - Ulcerative Colitis Clinical Trials

An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

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

This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).

NCT ID: NCT03635112 Terminated - Crohn's Disease Clinical Trials

Efficacy and Safety of TD-1473 in Crohn's Disease

DIONE
Start date: November 19, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.

NCT ID: NCT03623321 Completed - Clinical trials for Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Start date: July 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.

NCT ID: NCT03595566 Completed - Clinical trials for Clostridioides Difficile Infection

To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Ri-CoDIFy 2
Start date: January 28, 2019
Phase: Phase 3
Study type: Interventional

Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects with vancomycin. A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted. The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

NCT ID: NCT03594838 Completed - Clinical trials for Hepatitis C, Chronic

Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia

HEAD-Start
Start date: May 21, 2018
Phase: N/A
Study type: Interventional

This study will evaluate two novel approaches to improve access to Hepatitis C virus (HCV) confirmatory viremia testing. Both approaches are "Harm reduction site-based (HRS)" because HCV viremia testing will be initiated and test results will be provided at the HRSs. These approaches will be compared to the current standard of care (control) in which anti-HCV-positive individuals must travel to a HCV treatment centre for HCV viremia testing. The investigators hypothesize that improving access to viremia testing improves linkage to care and reduces loss to follow-up among those who screen anti-HCV-positive.

NCT ID: NCT03575052 Completed - Clinical trials for Neuropsychiatric Symptoms Related to Neurodegenerative Disease

A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Start date: May 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease.

NCT ID: NCT03558152 Completed - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Start date: October 26, 2018
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.