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NCT ID: NCT03078634 Completed - Clinical trials for Irritable Bowel Syndrome

The Multi-disciplinary Treatment of Functional Gut Disorders Study

MANTRA
Start date: March 16, 2017
Phase: N/A
Study type: Interventional

Randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be assessed.

NCT ID: NCT03078582 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients

Start date: March 8, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of zilucoplan (RA101495) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients in the study: the first group will include patients who have never received eculizumab for treatment of PNH. The second group will include patients who have received treatment with eculizumab for at least 6 months prior to the study. Patients will be treated with RA101495 for 12 weeks.

NCT ID: NCT03078036 Completed - Breast Cancer Clinical Trials

International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study

BREAKOUT
Start date: March 13, 2017
Phase:
Study type: Observational

BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.

NCT ID: NCT03075696 Recruiting - Clinical trials for Non-Hodgkin's Lymphoma

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Start date: February 21, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-to-human study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.

NCT ID: NCT03075215 Completed - Heart Failure Clinical Trials

Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry

SMART Registry
Start date: April 14, 2017
Phase:
Study type: Observational [Patient Registry]

To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others. A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

NCT ID: NCT03073967 Recruiting - HSV Infection Clinical Trials

Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects

PRIOH-1
Start date: May 8, 2017
Phase: Phase 3
Study type: Interventional

Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).

NCT ID: NCT03073486 Completed - Acne Vulgaris Clinical Trials

A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Start date: February 6, 2017
Phase: Phase 3
Study type: Interventional

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris

NCT ID: NCT03073278 Recruiting - Clinical trials for Locally Recurrent Prostate Cancer

Focal Radiotherapy for Previously Treated Prostate Cancer Patients

Start date: April 24, 2017
Phase: N/A
Study type: Interventional

To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.

NCT ID: NCT03072953 Terminated - Clinical trials for Pyoderma Gangrenosum

Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum

Start date: June 7, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 2a, open label, proof-of-concept clinical study is to assess the efficacy and safety of etrasimod (APD334) in patients with Pyoderma Gangrenosum.

NCT ID: NCT03072238 Completed - Clinical trials for Metastatic Prostate Cancer

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

IPATential150
Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).