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NCT ID: NCT03133988 Approved for marketing - Clinical trials for HER2-positive Breast Cancer

Margetuximab Expanded Access Program

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

The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.

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: 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: 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: NCT03245424 Approved for marketing - Clinical trials for Acute Myeloid Leukemia

Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation

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

To provide access to ivosidenib monotherapy to patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation.

NCT ID: NCT03245528 Approved for marketing - Sepsis Clinical Trials

Expanded Access for LJPC-501

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

The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

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: NCT03278314 Approved for marketing - Cystic Fibrosis Clinical Trials

Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis

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

To provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719). To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of age and older, homozygous for F508del.

NCT ID: NCT03400098 Approved for marketing - Clinical trials for Amyloidosis, Hereditary

ATTR Expanded Access Program (EAP) by Ionis

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

The purpose of this program is to provide expanded access to Inotersen for up to 100 Patients with Hereditary Transthyretin Amyloidosis (hTTR).

NCT ID: NCT03501615 Approved for marketing - Clinical trials for Relapsed/Refractory Hairy Cell Leukemia

An Early Access Programme for Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia

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

Early Access Programme to provide treatment access to moxetumomab pasudotox for eligible patients with relapsed/refractory hairy cell leukemia