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NCT ID: NCT01825395 Approved for marketing - Clinical trials for Lambert Eaton Myasthenic Syndrome

Use of 3,4-Diaminopyridine in the Treatment of Lambert-Eaton Syndrome

3 4-DAP
Start date: n/a
Phase:
Study type: Expanded Access

To learn more about the effect of 3, 4-Diaminopyridine (3,4-DAP) on patient diagnosed with Lambert-Eaton myasthenic syndrome (LEMS).

NCT ID: NCT01683110 Approved for marketing - Clinical trials for Medullary Thyroid Cancer

Expanded Access of Cabozantinib in Medullary Thyroid Cancer

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

The objective of this study is to provide access to cabozantinib for eligible subjects with medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by the FDA and commercial availability of cabozantinib.

NCT ID: NCT01649284 Approved for marketing - Clinical trials for Carcinoma, Non-Small-Cell Lung

Afatinib Expanded Access Program

Start date: July 2012
Phase: N/A
Study type: Expanded Access

This is an open-label, multi-center, single-arm trial, designed to provide early access to afatinib and to provide additional information on the safety and efficacy of afatinib in advanced NSCLC patients who harbor an EGFR mutation.

NCT ID: NCT01632826 Approved for marketing - Multiple Myeloma Clinical Trials

Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

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

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available

NCT ID: NCT01592136 Approved for marketing - Clinical trials for Chronic Myeloid Leukemia (CML)

Expanded Access Program of Ponatinib

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

This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.

NCT ID: NCT01476163 Approved for marketing - Fabry Disease Clinical Trials

Physician Initiated Expanded Access Request for Migalastat in Individual Patients With Fabry Disease

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

This program allows physicians to request permission from Amicus Therapeutics (Amicus) for treatment access to migalastat hydrochloride (HCl) for specific adult patients with Fabry disease. Treatment is open label for 6 months with renewal every 6 months.

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.

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: 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: 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.