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NCT ID: NCT01217697 Approved for marketing - Clinical trials for Urogenital Neoplasms

Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

NCT ID: NCT01220531 Approved for marketing - DiGeorge Syndrome Clinical Trials

Thymus Transplantation Safety-Efficacy

Start date: n/a
Phase:
Study type: Expanded Access

Complete DiGeorge anomaly (cDGA) is a disorder in which there is no thymus function. With no thymus function, bone marrow stem cells do not develop into educated T cells, which fight infection. Without successful treatment, patients with cDGA must remain in reverse isolation to prevent infection and subsequent death. Cultured thymus tissue with and without immunosuppression (drugs given before and after implantation) has resulted in the development of good T cell function in subjects with complete DiGeorge anomaly. This expanded access study continues cultured thymus tissue safety and efficacy research for the treatment of complete DiGeorge anomaly. Eligible participants receive cultured thymus tissue. Immune function testing is continued for one year post-implantation.

NCT ID: NCT01242891 Approved for marketing - Heart Failure Clinical Trials

Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol

CAP
Start date: n/a
Phase: N/A
Study type: Expanded Access

The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.

NCT ID: NCT01297933 Approved for marketing - Clinical trials for Short Bowel Syndrome

Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease

Omegaven
Start date: n/a
Phase:
Study type: Expanded Access

A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).

NCT ID: NCT01327742 Approved for marketing - Clinical trials for Thoracic Aortic Aneurysm

Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

Start date: n/a
Phase: N/A
Study type: Expanded Access

This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms. Efficacy is being evaluated by the device-related adverse event rate of endovascular repair (via the Relay thoracic stent-graft) through 1 year. Safety is being evaluated by comparing major adverse events through 1 year in subjects treated with the Relay thoracic stent-graft to those who underwent surgical repair.

NCT ID: NCT01377532 Approved for marketing - Pheochromocytoma Clinical Trials

Compassionate Use of 131I-MIBG for Patients With Malignant Pheochromocytoma

Start date: n/a
Phase:
Study type: Expanded Access

This is a compassionate use protocol to allow palliative therapy for patients with malignant pheochromocytoma and paragangliomas.

NCT ID: NCT01381289 Approved for marketing - Cystic Fibrosis Clinical Trials

VX-770 Expanded Access Program

Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this expanded access program is to provide VX-770 prior to its commercial availability to people with cystic fibrosis (CF) who have at least one copy of the G551D-CFTR mutation and who are in critical medical need and who are not eligible for participation in other Vertex-sponsored studies.

NCT ID: NCT01410500 Approved for marketing - Multiple Myeloma Clinical Trials

Carfilzomib Multiple Myeloma Expanded Access Protocol for Patients With Relapsed and Refractory Disease

Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is to expand upon the safety data for carfilzomib by providing expanded access to patients with relapsed and refractory multiple myeloma who are unable to enroll in any other ongoing carfilzomib trial.

NCT ID: NCT01412359 Approved for marketing - Clinical trials for Total Parenteral Nutrition-induced Cholestasis

Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Associated Hepatic Injury

Start date: n/a
Phase:
Study type: Expanded Access

The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated cholestasis. It is a compassionate use protocol for patients who already have significant cholestasis related to parenteral nutrition.

NCT ID: NCT01425567 Approved for marketing - Liver Disease Clinical Trials

Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury

Omegaven
Start date: n/a
Phase:
Study type: Expanded Access

To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.