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NCT ID: NCT02577562 Approved for marketing - Clinical trials for Abdominal Aortic Aneurysms

Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

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

The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

NCT ID: NCT02533115 Approved for marketing - Secondary AML Clinical Trials

EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML

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

This study is a Phase IV Expanded Access Protocol (EAP) of CPX-351 in patients with secondary acute myeloid leukemia who are suitable for treatment with intensive chemotherapy.

NCT ID: NCT02496689 Approved for marketing - Hypophosphatasia Clinical Trials

Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)

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

This clinical trial is being conducted in Hypophosphatasia, a bone disorder caused by gene mutation(s) resulting in bone defects. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study is to provide access to treatment in a disease where no approved treatment exists. This is an experimental treatment provided under specific treatment guidelines in which safety endpoints will be collected.

NCT ID: NCT02477891 Approved for marketing - Multiple Myeloma Clinical Trials

Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

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

The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.

NCT ID: NCT02471781 Approved for marketing - Aortic Aneurysm Clinical Trials

Zenith® TX2® Low Profile TAA Endovascular Graft

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

The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.

NCT ID: NCT02464943 Approved for marketing - Aortic Dissection Clinical Trials

Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections

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

The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.

NCT ID: NCT02355054 Approved for marketing - Clinical trials for Cancer of the Prostate

Detecting Recurrent Prostate Cancer With C-11 Choline Positron Emission Tomography: An Expanded Access Study

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

The purpose of this study is to provide clinical access to PET/CT and PET/MRI with C-11 choline for evaluation of men with biochemically recurrent prostate cancer while awaiting approval of the Washington University Abbreviated New Drug Application for C-11 choline.

NCT ID: NCT02328768 Approved for marketing - Clinical trials for Total Parenteral Nutrition-Induced Cholestasis

Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children

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 liver disease. It is a compassionate use protocol for patients who already have significant liver disease related to parenteral nutrition.

NCT ID: NCT02286492 Approved for marketing - Clinical trials for Colorectal Cancer Metastatic

Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer

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

The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

NCT ID: NCT02244775 Approved for marketing - Clinical trials for Arthroplasty of the MCP Joint

Use of Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis, Humanitarian Use Device

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

The purpose of this study is to allow patients to undergo surgery with the SR™ MCP (Metacarpophalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device.