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NCT ID: NCT03533361 Approved for marketing - Thyroid Cancer Clinical Trials

Expanded Access Program With Lenvatinib for the Treatment of Differentiated Thyroid Cancer in Brazil

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

This is an Expanded Access Program to make lenvatinib available to participants with radioiodine-refractory differentiated thyroid cancer in Brazil. Participants who have no other treatment options available, and who, in the opinion and clinical judgment of the treating physician, would benefit from treatment with lenvatinib will be enrolled. This is a multicenter, open-label program consisting of 2 phases: a 28-day pretreatment phase (including screening) and a treatment phase. Treatment will be provided as long as there is a clinical benefit based on tumor assessments performed according to the center's standard of care and the judgment of the participant's treating physician.

NCT ID: NCT03561194 Approved for marketing - Clinical trials for Parenteral Nutrition Associated Liver Disease

Omegaven Protocol:Intermediate Size Patient Population

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

Children requiring prolonged courses of PN are at risk for developing PN associated liver disease. We hypothesize that although omega-6 fatty acid emulsions prevent fatty acid deficiency, they are not cleared in a manner similar to enteral chylomicrons and therefore accumulate in the liver and resulting in steatotic liver injury. We further hypothesize that a fat emulsion comprised of omega-3 fatty acids (i.e., fish oil) such as Omegaven® would be beneficial in the management of steatotic liver injury by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.

NCT ID: NCT03723135 Approved for marketing - Clinical trials for Acute Myelogenous Leukemia (AML)

Expanded Access for CC-486

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

This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.

NCT ID: NCT03780127 Approved for marketing - Dravet Syndrome Clinical Trials

ZX008 Expanded Access Protocol

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

The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 clinical trials.

NCT ID: NCT03780140 Approved for marketing - Clinical trials for Bacterial Infections

Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections

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

Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.

NCT ID: NCT03791567 Approved for marketing - Clinical trials for Type 1 Diabetes Mellitus

Islet Transplantation in Type I Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

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

A Phase 3 clinical trial has been completed and demonstrated the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol.The objective in offering expanded access to donislecel (allogeneic islets of Langerhans for transplant; IND BB-11807) for the treatment of brittle T1D is to bridge the gap between completed clinical trials and marketing (i.e. approval by the FDA of a biological license application). Expanded access will allow clinical trial subjects, as well as patients outside a clinical trial, to receive treatment. New patients participating in the expanded access protocol are required to meet exclusion and inclusion criteria.

NCT ID: NCT03817515 Approved for marketing - TSC1 Clinical Trials

Expanded Access for ABI-009 in Patients With Advanced PEComa and Patients With a Malignancy With Relevant Genetic Mutations or mTOR Pathway Activation

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

Expanded Access for an Intermediate-size Population for ABI-009 (Sirolimus Albumin-bound Nanoparticles for Injectable Suspension) in Patients with Advanced Perivascular Epithelioid Cell Tumors (PEComa) and Patients with a Malignancy with Relevant Genetic Mutations or mTOR Pathway Activation

NCT ID: NCT03825484 Approved for marketing - Clinical trials for Advanced Cancers and FGFR Genetic Alterations

Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options

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

The purpose of this program is to provide participants an early access to erdafitinib prior to market authorization (that is, Food and Drug Administration [FDA] approval in the United States). The program is limited to participants with advanced cancers and fibroblast growth factor receptor (FGFR) genetic alterations who have exhausted at least 2 lines of standard of care therapy and who are not eligible for an erdafitinib clinical trial.

NCT ID: NCT03829579 Approved for marketing - Clinical trials for Depressive Disorder, Treatment-Resistant

Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)

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

This is a pre-approval access program (PAAP) for eligible participants. The main purpose of this program is to provide access to esketamine nasal spray to eligible participant with treatment-resistant depression (TRD), who have exhausted all other treatment options, including all alternative treatment options with marketed therapies.

NCT ID: NCT03843892 Approved for marketing - Clinical trials for Lung Diseases, Interstitial

An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities

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

This Expanded Access Program is intended to facilitate the availability of OFEV to patients suffering from non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) with a progressive clinical course despite Standard of Care treatment and for whom no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial.