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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: 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: NCT02762591 Approved for marketing - Clinical trials for Parkinson's Disease Psychosis

Expanded Access of Pimavanserin for Patients With PD Psychosis

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

The purpose of this program is to provide patients with PDP access to pimavanserin until the product receives marketing approval from the FDA and is commercially available.

NCT ID: NCT02778698 Approved for marketing - Cholestasis Clinical Trials

Compassionate Use of Omegaven

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

This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver. It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury. Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.

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: 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: 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: NCT02939820 Approved for marketing - Clinical trials for Amyloidosis, Hereditary

Expanded Access Protocol of Patisiran for Patients With Hereditary ATTR Amyloidosis (hATTR)

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

The purpose of this study is to provide expanded access of patisiran to patients with hereditary transthyretin-mediated amyloidosis (hATTR).

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: 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.