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NCT ID: NCT03554434 No longer available - Breast Cancer Clinical Trials

An Expanded Access Program for AM0010 (Pegilodecakin)

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

This is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.

NCT ID: NCT03559673 No longer available - Epilepsies, Partial Clinical Trials

Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures

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

The objective of this Compassionate Use Program (CUP) is to provide continued access to Lacosamide (LCM) for monotherapy use for patients who were receiving LCM in SP0993 and SP0994 at the time of study unblinding and close of SP0994, and who benefited from the treatment per investigator assessment.

NCT ID: NCT03564964 No longer available - Alzheimer Disease Clinical Trials

Expanded Access to Provide SUVN-502 for the Treatment of Subjects With Alzheimer's Disease

SUVN-502
Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to SUVN-502 for the treatment of Alzheimer's Disease. Investigator as well as the subject/caregiver must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria. Subjects will not be evaluated for efficacy and safety during the expanded access.

NCT ID: NCT03582930 No longer available - Clinical trials for Neonatal Respiratory Distress

Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)

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

Surfactant replacement therapy can be life-saving for newborn infants born with symptomatic lung surfactant deficiency causing Respiratory Distress Syndrome (RDS). Currently, such therapy requires instillation of a liquid suspension into the trachea through an endotracheal tube. Endotracheal intubations have undesirable adverse effects on fragile premature infants. Instilling surfactant as a liquid suspension into the lung is associated with adverse events due to interruption of breathing in patients who already have respiratory insufficiency. This treatment protocol is expanded access that offers the opportunity for patients to receive aerosolized Infasurf prior to FDA acting on ONY Biotech's application for approval for commercial marketing of aerosolized Infasurf.

NCT ID: NCT03592576 No longer available - Myelofibrosis Clinical Trials

Expanded Access to Navitoclax

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

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to navitoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

NCT ID: NCT03593499 No longer available - Melanoma Clinical Trials

Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401

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

This is an expanded access program for eligible participants and is designed to provide access to omaveloxolone for the treatment of unresectable or metastatic melanoma to patients who previously participated in the 408-C-1401 (REVEAL) study. To be considered for expanded access, a Principal Investigator from the REVEAL trial should submit a request to Reata Pharmaceuticals on behalf of the individual patient.

NCT ID: NCT03594162 No longer available - Clinical trials for Acute Lymphoblastic Leukemia

Compassionate Use of CAR T Cells Targeting the CD19 Antigen and Containing the Inducible Caspase 9 Safety Switch

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

This protocol for compassionate use combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This protocol combines both T cells and antibodies to create a more effective treatment. The investigational treatment is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD19 antigen (ATLCAR.CD19) administration. Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD19. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD19. For this protocol, the anti-CD19 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD19 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown. Preliminary results have shown that many subjects receiving this treatment have experienced unwanted side effects including cytokine release syndrome. In this protocol, to help reduce cytokine release syndrome symptoms, the ATLCAR.CD19 cells have a safety switch that when active, can cause the cells to become dormant. These modified ATLCAR.CD19 cells with the safety switch are referred to as iC9-CAR19 cells. If the patient experiences moderate to severe cytokine release syndrome as a result of being given iC9-CAR19 cells, the patient can be given a dose of a second study drug, AP1903, if standard interventions fail to alleviate the symptoms of cytokine release syndrome. AP1903 activates the iC9-CAR19 safety switch, reducing the number of the iC9-CAR19 cells in the blood. The primary purpose of this protocol is to treat a single patient with a second dose of iC9-CAR19 T cells.

NCT ID: NCT03624842 No longer available - Clinical trials for Late Onset Alzheimer Disease

Expanded Access With Trappsol(R) Cyclo (TM) for an Individual Patient With Late Onset Alzheimer's Disease

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

To afford urgent access to a potential-disease modifying treatment, Dr. Diana Kerwin, in partnership with CTD Holdings, the manufacturer of Trappsol (R) Cyclo(TM), will administer the product to a patient with Alzheimer's Disease who has no other disease-modifying treatment options.

NCT ID: NCT03639844 No longer available - Clinical trials for Inborn Errors of Metabolism

BPX-501 T Cells Infused Post Stem Cell Transplant in Pediatrics With Non-Malignant Disorders Ineligible for BPU004 Study

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

Providing access of BPX-501 gene modified T cells and rimiducid to pediatric patients who do not meet the eligibility criteria of the BP-U-004 study.

NCT ID: NCT03642691 No longer available - Hypoplasminogenemia Clinical Trials

A Treatment Protocol for Expanded Access Administration of Prometic Plasminogen Due to Closure of Clinical Trial

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

The clinical trial is no longer enrolling and is currently closing and Prometic will continue to provide Plasminogen (Human) under a treatment protocol to subjects in the United States (US) with hypoplasminogenemia requiring plasminogen replacement therapy who completed the End of Study visit in the following Prometic-sponsored clinical trials: 2002C011G, 2002C013G, 2002C016G, 2002C017G and 2002C019G.