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NCT ID: NCT02342886 Completed - Clinical trials for Tuberculosis, Pulmonary, Multi Drug-resistant

Shortening Treatment by Advancing Novel Drugs

STAND
Start date: February 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard HRZE treatment. This study will also assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin, PA-824, and pyrazinamide treatments in DS-TB subjects.

NCT ID: NCT02339207 Completed - Chronic Hepatitis C Clinical Trials

First in Human Study of AL-335; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1

Start date: December 31, 2014
Phase: Phase 1
Study type: Interventional

This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV) and subjects with CHC infection.

NCT ID: NCT02319044 Completed - Clinical trials for Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck

Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck

Start date: April 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.

NCT ID: NCT02314754 Completed - Medical Abortion Clinical Trials

Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation

XXGA
Start date: December 2014
Phase: Phase 4
Study type: Interventional

To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.

NCT ID: NCT02309359 Completed - Clinical trials for Rheumatoid Arthritis

A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

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

The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo. To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.

NCT ID: NCT02294058 Completed - Multiple Sclerosis Clinical Trials

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

SUNBEAM
Start date: December 3, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

NCT ID: NCT02287922 Completed - Clinical trials for Rheumatoid Arthritis

A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

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

The primary objective of this study is: - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA). The secondary objectives of this study are: - To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical development. - To obtain parallel descriptive information concerning the efficacy and safety of tocilizumab (TCZ) s.c. in the same clinical trial RA population.

NCT ID: NCT02279524 Completed - Liver Diseases Clinical Trials

A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH

Aramchol_005
Start date: April 29, 2015
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic. Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1. The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

NCT ID: NCT02278718 Active, not recruiting - Thermal Burns Clinical Trials

A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care

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

This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

NCT ID: NCT02278341 Completed - Anemia Clinical Trials

Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

Pyrenees
Start date: November 21, 2014
Phase: Phase 3
Study type: Interventional

This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.