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NCT ID: NCT02279862 Completed - Prostate Cancer Clinical Trials

Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive

Start date: December 2, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

NCT ID: NCT02279745 Completed - Clinical trials for Pulmonary Arterial Hypertension

Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

Start date: July 8, 2015
Phase: Phase 2
Study type: Interventional

This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical worsening.

NCT ID: NCT02279654 Completed - Clinical trials for Myelodysplastic Syndrome

Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

PASS MDS del5q
Start date: December 17, 2014
Phase:
Study type: Observational [Patient Registry]

This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)]. The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.

NCT ID: NCT02279511 Completed - Alzheimer's Disease Clinical Trials

ATP in Alzheimer Disease

Start date: December 2014
Phase: Phase 2
Study type: Interventional

To Check whether systemic treatment with ATP alters the profile of cerebral metabolism in patients with Alzheimer's disease using MRS techniques (Magnetic Resonance Spectroscopy) and adjust the infusion (minimum effective dose) that promotes this metabolic change.

NCT ID: NCT02279498 Completed - Cystic Fibrosis Clinical Trials

SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis

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

Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI). Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.

NCT ID: NCT02279173 Completed - Clinical trials for Immune Thrombocytopenia

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)

Start date: December 10, 2014
Phase: Phase 3
Study type: Interventional

This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the past 4 weeks.

NCT ID: NCT02279160 Completed - Clinical trials for Pulmonary Arterial Hypertension

Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

Start date: December 2014
Phase: Phase 2
Study type: Interventional

The study was conducted as a placebo-controlled, randomized, 22-week double-blind study which included a dose titration period. An additional transition period occurred for those patients who elected to enroll into the open-label extension study, APD811-007. A total of 61 patients with PAH were enrolled.

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.

NCT ID: NCT02278250 Completed - Solid Tumor Clinical Trials

First in Human Study of M4344 in Participants With Advanced Solid Tumors

Start date: January 26, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin to determine the safety and maximum tolerated dose.

NCT ID: NCT02278133 Completed - Clinical trials for Metastatic Colorectal Cancer

Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions. The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.