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NCT ID: NCT01626404 Completed - Clinical trials for Advanced Heart Failure

Screening for Advanced Heart Failure Treatment (SEE-HF)

SEE-HF
Start date: October 2012
Phase:
Study type: Observational

Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.

NCT ID: NCT01626378 Completed - Clinical trials for Behavioral Variant Frontotemporal Dementia (bvFTD)

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Behavioral Variant Frontotemporal Dementia (bvFTD)

Start date: May 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the safety and efficacy of TRx0237 in the treatment of patients with behavioral variant frontotemporal dementia (bvFTD).

NCT ID: NCT01625806 Completed - Healthy Volunteer Clinical Trials

A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers

Start date: July 2012
Phase: Phase 1
Study type: Interventional

This single-center, open-label, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours) from Day 1 to Day 17.

NCT ID: NCT01625390 Completed - Clinical trials for Hemophilia A, Hemophilia B

A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150

Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability. The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process. The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months. Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study. Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.

NCT ID: NCT01625338 Completed - Chronic Hepatitis C Clinical Trials

Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Start date: June 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

NCT ID: NCT01625182 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Start date: December 22, 2012
Phase: Phase 3
Study type: Interventional

The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

NCT ID: NCT01624870 Completed - Clinical trials for Aortic Valve Stenosis

CoreValve Advance-II Study: Prospective International Post-market Study

Advance-II
Start date: October 2011
Phase:
Study type: Observational

The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.

NCT ID: NCT01624142 Completed - Clinical trials for Severe Familial Hypercholesterolemia

Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders

TAUSSIG
Start date: June 1, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

NCT ID: NCT01623115 Completed - Clinical trials for Hypercholesterolemia

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

ODYSSEY FH I
Start date: July 2012
Phase: Phase 3
Study type: Interventional

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points - To evaluate the effects of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab

NCT ID: NCT01622764 Withdrawn - Glioblastoma Clinical Trials

89Zr-RO5323441 PET Imaging in Glioblastoma

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

The research the investigators propose is a molecular imaging study of RO5323441, an antibody against placental growth factor (PlGF) in patients with recurrent GBM treated with bevacizumab, a drug against vascular endothelial growth factor (VEGF). Both VEGF and PlGF are molecules involved in tumor growth since they enable the development of tumor vasculature, thus delivery of oxygen and nutrients to the tumor. The treatment will consist of bevacizumab (i.v.) given every 2 weeks, until the patient has clinical benefit (no disease progression) or unacceptable toxicity. Meanwhile, patients will receive and injection of low protein-dose radiolabeled RO5323441 (89Zr-RO5323441) on day -3 and 11 of the first bevacizumab treatment cycle. Brain-only 89Zr-RO5323441 positron emission tomography (PET) will be performed at 2 hours after each injection of 89Zr-RO5323441 on day -3 and 11. Whole body 89Zr-RO5323441 PET will be performed on day 1 and 15, before and after the first treatment with bevacizumab. The main purpose of this trial is to determine how much of RO5323441 actually gets into the recurrent GBM lesions, since for a drug to be active, it has to be able to reach cancer cells. As second aims, RO5323441 accumulation in normal, non-tumor organs, will be assessed, as well as how bevacizumab influences RO5323441 penetration into tumor lesions (to answer the question of combined bevacizumab + RO5323441 treatment in GBM) or RO5323441 biodistribution in non-tumor organs.