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NCT ID: NCT03604198 Enrolling by invitation - Cushing Syndrome Clinical Trials

Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

Start date: May 7, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

NCT ID: NCT03603314 Completed - Clinical trials for Severe Sudden Sensorineural Hearing Loss

Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

AUDIBLE-S
Start date: February 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period

NCT ID: NCT03599245 Active, not recruiting - Multiple Sclerosis Clinical Trials

This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

Start date: July 12, 2018
Phase: Phase 3
Study type: Interventional

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

NCT ID: NCT03597022 Terminated - Hemophilia A and B Clinical Trials

Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors

Start date: July 24, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the safety and tolerability of multiple doses of a human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or B. This antibody was intended to protect from bleeds by inhibiting a substance (Tissue Factor Pathway Inhibitor, TFPI) that reduces the ability of the body to form blood clots.

NCT ID: NCT03595553 Completed - Clinical trials for Clostridioides Difficile Infection

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

Ri-CoDIFy 1
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 treated 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. Ridinilazole plasma concentration will be assessed in a subset of patients.

NCT ID: NCT03593590 Active, not recruiting - Multiple Sclerosis Clinical Trials

Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

MuSicalE
Start date: November 12, 2018
Phase:
Study type: Observational

This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.

NCT ID: NCT03593213 Terminated - Schizophrenia Clinical Trials

Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia

Start date: July 30, 2018
Phase: Phase 3
Study type: Interventional

1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia 2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d

NCT ID: NCT03593200 Completed - PNH Clinical Trials

A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With PNH

Start date: August 16, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase IIa, open-label, multiple dose, study in patients with PNH who have not received eculizumab (Soliris ®) in the past. A single cohort of subjects is planned for evaluation.

NCT ID: NCT03590379 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)

TRI-D
Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD

NCT ID: NCT03589326 Active, not recruiting - Clinical trials for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

Start date: October 4, 2018
Phase: Phase 3
Study type: Interventional

In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.