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NCT ID: NCT01890746 Completed - Acute Leukaemia Clinical Trials

A Safety and Efficacy Study of Eltrombopag in Subjects With AML

Start date: September 5, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, blinded, placebo-controlled study was to provide clinical safety and exploratory efficacy data on the use of Eltrombopag in adult subjects with Acute Myeloid Leukemia (AML) receiving standard induction chemotherapy with daunorubicin plus cytarabine. A minimum of 120 evaluable subjects newly diagnosed with AML was stratified by antecedent malignant hematologic disorder and age.

NCT ID: NCT01890655 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Extension Study of MT-1303

Start date: August 2013
Phase: Phase 2
Study type: Interventional

To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).

NCT ID: NCT01889433 Completed - Hepatitis C Clinical Trials

An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C

Start date: July 10, 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.

NCT ID: NCT01888874 Completed - Clinical trials for Rheumatoid Arthritis

Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)

DARWIN1
Start date: July 17, 2013
Phase: Phase 2
Study type: Interventional

Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks. •During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.

NCT ID: NCT01888484 Completed - Clinical trials for Primary Immune Deficiency Disorder

Study of Octanorm Subcutaneous IG in Patients With PID

Start date: March 2014
Phase: Phase 3
Study type: Interventional

This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a 12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm in preventing serious bacterial infections (SBI) compared with historical control data and to evaluate the pharmacokinetic (PK) characteristics of octanorm.

NCT ID: NCT01888432 Completed - Clinical trials for Liver Transplantation

Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

NCT ID: NCT01887600 Completed - Clinical trials for Anemia in Chronic Kidney Disease in Non-dialysis Patients

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis

ALPS
Start date: September 3, 2013
Phase: Phase 3
Study type: Interventional

This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.

NCT ID: NCT01885624 Completed - Clinical trials for Adult Healthy Volunteers

Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers

Start date: November 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.

NCT ID: NCT01885078 Completed - Clinical trials for Rheumatoid Arthritis

An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

RA-BEYOND
Start date: June 27, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib.

NCT ID: NCT01884675 Completed - Hypertension Clinical Trials

Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.

AMBER I
Start date: September 2013
Phase: Phase 3
Study type: Interventional

It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel group, 16 week study will compare the safety and efficacy of ambrisentan 5 milligrams (mg) versus placebo in subjects with inoperable CTEPH. The study will enrol 160 subjects, to assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out rate.