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NCT ID: NCT02963350 Approved for marketing - CLN2 Disease Clinical Trials

A Multicenter, Multi-national Open-label Program to Provide BMN 190 to Patients Diagnosed With CLN2 Disease

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

- To provide access to BMN 190 to patients with CLN2 disease who cannot participate in a clinical trial. - To collect additional information on the safety and tolerability of BMN 190 administration in patients with CLN2 disease.

NCT ID: NCT02961491 Approved for marketing - Pheochromocytoma Clinical Trials

Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

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

The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with iobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).

NCT ID: NCT02929303 Approved for marketing - Clinical trials for Total Parenteral Nutrition-induced Cholestasis

Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

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

This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin. This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.

NCT ID: NCT02792725 Approved for marketing - Clinical trials for Metastatic Breast Cancer

Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer

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

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

NCT ID: NCT02780193 Approved for marketing - Cholestasis Clinical Trials

Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury

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

The purpose of this study is to provide intravenous omega-3 fatty acids and monitor tolerance in subjects with prolonged parenteral nutrition dependence and parenteral nutrition-associated cholestasis through expanded access.

NCT ID: NCT02705313 Approved for marketing - Clinical trials for Neuroendocrine Tumors

EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx

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

Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

NCT ID: NCT02695030 Approved for marketing - Clinical trials for Giant Wide Necked Aneurysms

Low-profile Visualized Intraluminal Support -HUD

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

The MicroVention Low-profile Visualized Intraluminal Support (LVIS*) Device is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck (neck greater than or equal to 4 or a dome to neck ratio less than two), intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than or equal to 2.5mm and less than or equal to 4.5mm.

NCT ID: NCT02660255 Approved for marketing - Epilepsy Clinical Trials

Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy

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

This is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol.

NCT ID: NCT02592941 Approved for marketing - Clinical trials for Duchenne Muscular Dystrophy

Deflazacort Expanded Access Program for Children, Adolescents and Adults With Duchenne Muscular Dystrophy

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

The expanded access program will provide access to treatment with deflazacort in children, adolescent, and adult patients with DMD in the U.S. who are ineligible, unable, or otherwise unwilling to enroll in a clinical study examining the efficacy of deflazacort while a new drug application is under preparation and review. Enrollment is open to all eligible patients.

NCT ID: NCT02589717 Approved for marketing - Clinical trials for Urothelial Carcinoma

An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy

Start date: November 2015
Phase: Phase 4
Study type: Expanded Access

This is an open-label, multicenter, single-arm, expanded access program (EAP) designed to provide atezolizumab access to participants with locally advanced or metastatic urothelial carcinoma that has progressed on, or is intolerant to, a platinum-containing chemotherapy regimen.