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NCT ID: NCT04513860 Approved for marketing - Partial Epilepsy Clinical Trials

Cenobamate Expanded Access Program (EAP)

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

This Cenobamate Expanded Access Program (EAP) is designed to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013, YKP3089C017 or YKP3089C021.

NCT ID: NCT04530994 Approved for marketing - Alagille Syndrome Clinical Trials

A Maralixibat Expanded Access Program for Patients With Cholestatic Pruritus Associated With Alagille Syndrome (ALGS)

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

An open-label, single-arm, multi-centre program providing treatment access to ALGS patients with cholestatic pruritus in the US. Access can be requested through Clinigen Healthcare Ltd via email MirumALGS@clinigengroup.com or telephone +1-877-768-4303.

NCT ID: NCT04534322 Approved for marketing - Clinical trials for Relapsed and/or Refractory Multiple Myeloma

Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma

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

To provide early treatment access and evaluate the safety of melflufen and dexamethasone in patients with triple class refractory (TCR) multiple myeloma (MM).

NCT ID: NCT04535557 Approved for marketing - Clinical trials for Carcinoma, Non-Small-Cell Lung

An Expanded Access Protocol for Mobocertinib in Refractory Non-small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Exon20 Insertion Mutations

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

The purpose of this study is to provide expanded compassionate use access to mobocertinib, in participants with locally advanced or metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations and who have received at least 1 prior line of therapy for locally advanced or metastatic disease.

NCT ID: NCT04599712 Approved for marketing - Clinical trials for Metastatic Non-Small Cell Lung Cancer

Pre-Approval Access With Amivantamab (JNJ-61186372) in Participants With Metastatic Non-Small Cell Lung Cancer

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

The purpose of this expanded access program (EAP) is to provide amivantamab for the treatment of participants with metastatic non-small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations, and whose disease has progressed during or after current standard of care platinum-based chemotherapy. This intermediate EAP may be considered for individuals with serious/life-threatening diseases or conditions, where there are no alternative treatments or where individuals have progressed following standard of care.

NCT ID: NCT04702360 Approved for marketing - Cystic Fibrosis Clinical Trials

ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation

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

The purpose of this program is to provide elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) to CF patients in critical need who are 6 to 11 years of age with at least one F508del mutation in response to unsolicited physician requests.

NCT ID: NCT04777734 Approved for marketing - Clinical trials for Generalized Myasthenia Gravis

Efgartigimod Expanded Access for Generalized Myasthenia Gravis

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

This expanded access protocol applies to patients with gMG who are not enrolled in an ongoing clinical trial. The aim of the trial is to provide patients with generalized myasthenia gravis (gMG), who are ineligible to participate in a clinical trial, access to efgartigimod treatment before regulatory approval. There are country-specific protocols and also individual use EAP. Recruitment for the treatment protocol in US is now closed (ARGX-113-EAP-2101).

NCT ID: NCT04829422 Approved for marketing - Lung Cancer Clinical Trials

Early Access Program of Lazertinib in Republic of Korea

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

This early access program will be conducted to provide access to Lazertinib for adult patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with T790M mutation-positive after 1st/2nd generation EGFR TKIs Therapy.

NCT ID: NCT04877132 Approved for marketing - Clinical trials for Sphingomyelin Lipidosis

Compassionate Use Program for Olipudase Alfa Enzyme Replacement Therapy for Patients With Chronic Acid Sphingomyelinase Deficiency (ASMD)

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

The objective of this program is to provide access to enzyme replacement therapy (ERT) with olipudase alfa for certain patients with ASMD, a severe, life threatening disease, that could not participate in the olipudase clinical trials. The program will provide access to olipudase alfa prior to registration and the availability of commercial product (including reimbursement where applicable) in the country of the patient.

NCT ID: NCT04943952 Approved for marketing - Clinical trials for Acute Lymphoblastic Leukemia

JZP458 - Recombinant Erwinia Asparaginase for Treatment of ALL / LBL Patients With Hypersensitivity to E. Coli-derived Asparaginase

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

This study is an Expanded Access Protocol (EAP) of JZP458 in participants with ALL/LBL who are hypersensitive to an E.coli-derived asparaginase (allergic reaction or silent inactivation) and unable to access alternative licensed treatment, to receive JZP458 treatment prior to potential Food and Drug Administration (FDA) approval and commercial availability.