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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.

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: 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: NCT03259633 Approved for marketing - Clinical trials for NF type1 With Inoperable Plexiform Neurofibromas

An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1

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

This will be an open-label, single-arm, multicenter intermediate access protocol which provides treatment access to selumetinib for eligible patients with neurofibromatosis type 1 (NF1) who have inoperable, progressive/symptomatic plexiform neurofibromas (PN) without any alternative therapeutic options. All patients will continue to receive drug while they are deriving clinical benefit. Approximately 100 patients in the US will be treated as part of this protocol

NCT ID: NCT03154437 Approved for marketing - Hemophilia A Clinical Trials

An Expanded Access Program of Emicizumab in Participants With Hemophilia A With Inhibitors

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

This open-label, multicenter expanded access program (EAP) is designed to provide emicizumab to eligible participants with hemophilia A with factor VIII (FVIII) inhibitors before it is commercially available in the United States for the indication of hemophilia A with FVIII inhibitors. Discontinuation may occur earlier if participant or physician decides to discontinue treatment or the sponsor discontinues emicizumab clinical development.

NCT ID: NCT03153462 Approved for marketing - Clinical trials for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Axicabtagene Ciloleucel Expanded Access Study

ZUMA-9
Start date: n/a
Phase:
Study type: Expanded Access

A multicenter, open-label expanded access protocol for the treatment of subjects with relapsed/refractory large B-cell lymphoma. Subjects who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

NCT ID: NCT03147742 Approved for marketing - Clinical trials for Graft-versus-host Disease (GVHD)

An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

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

To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.

NCT ID: NCT03079687 Approved for marketing - Ovarian Cancer Clinical Trials

Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

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

This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other treatment options or eligible for an olaparib clinical trials.

NCT ID: NCT03072667 Approved for marketing - Liver Diseases Clinical Trials

Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease

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

This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and have not responded positively to currently available medical therapies. PNALD develops in newborns dependent on parenteral nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and nutritional fluids; although PN is necessary and life sustaining, it can result in severe liver disease.

NCT ID: NCT03070093 Approved for marketing - Clinical trials for Acute Myeloid Leukemia (AML)

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

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

The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery [CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to comparable or alternative therapy.