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NCT ID: NCT05345678 Approved for marketing - Clinical trials for Unresectable Hepatocellular Carcinoma

Himalaya Early Access Program

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

To provide early access (i.e., before marketing authorisation) to tremelimumab 300 mg IV administered once on Day 1 of Cycle 1 plus durvalumab 1500 mg IV followed by durvalumab 1500 mg IV Q4W monotherapy in patients with unresectable HCC.

NCT ID: NCT05286372 Approved for marketing - Clinical trials for Amyotrophic Lateral Sclerosis

An Intermediate Size Expanded Access Protocol of AMX0035 for ALS

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

The Expanded Access Program will provide access and assess the safety of AMX0035 for the treatment of people living with ALS.

NCT ID: NCT05162443 Approved for marketing - Metastatic Cancer Clinical Trials

Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation

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

The objective of this EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.

NCT ID: NCT04972487 Approved for marketing - Clinical trials for Superoxide Dismutase 1-Amyotropic Lateral Sclerosis

Expanded Access Program for Tofersen in Participants With Superoxide Dismutase 1-Amyotropic Lateral Sclerosis

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

The objective of this early access program (EAP) is to provide access to tofersen to eligible participants with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene prior to an alternative access mechanism in order to address a high unmet medical need in this population.

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: 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: 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: NCT04507503 Approved for marketing - Clinical trials for Advanced Cholangiocarcinoma

Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

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

The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.

NCT ID: NCT04483531 Approved for marketing - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

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

To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able to get to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteria for PEDFIC 2 after recruitment has been completed

NCT ID: NCT04452136 Approved for marketing - Prostate Cancer Clinical Trials

Expanded Access Protocol of 68Ga PSMA 11 PET Imaging of Prostate Cancer

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

This study provides expanded access to radiotracer Gallium 68 (68Ga)-prostate-specific membrane antigen (PSMA)-HBED-CC (68Ga-PSMA-11) with Positron Emission Tomography (PET) imaging for participants with intermediate and high risk prostate cancer before prostatectomy or for suspected biochemical recurrence of their prostate cancer. Compared to conventional imaging, 68Ga PSMA-HBED-CC might improve the ability to localize the sites of recurrent or metastatic disease, which helps with surgical and other treatment planning.