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NCT ID: NCT05760586 Available - Low-grade Glioma Clinical Trials

Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Glioma

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

The DAY101-EAP is a multicenter, open-label, expanded access treatment protocol designed to provide access to tovorafenib (DAY101) for eligible patients.

NCT ID: NCT05770219 Available - Clinical trials for Thrombotic Thrombocytopenic Purpura (TTP)

Expanded Access Program of TAK-755 for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

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

The expanded access program allows people to gain access to unlicensed treatment on compassionate grounds. TAK-755 also known as rADAMTS13, is a medicine that treats people born with severe congenital or hereditary thrombotic thrombocytopenic purpura (cTTP). This expanded access program enables continued access to those participants who have no other treatment options available for cTTP.

NCT ID: NCT05776134 Available - Clinical trials for Acute Lymphoblastic Leukemia

Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

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

The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.

NCT ID: NCT05776160 Available - Follicular Lymphoma Clinical Trials

Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

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

The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

NCT ID: NCT05779267 Available - Bipolar Depression Clinical Trials

NRX-101 Expanded Access

NRX-101EAP
Start date: n/a
Phase:
Study type: Expanded Access

There is no currently-approved pharmacotherapy for patients with Treatment-Resistant Bipolar Depression and Suicidal Ideation or behavior. The purpose of this Expanded Access Treatment Protocol is to make NRX-101 available to patients who have depression and suicidal ideation despite treatment with currently approved medication and to gather information on safety and efficacy in a real-world data environment. Participants will be treated by their own practicing psychiatrist and will agree to periodic psychometric evaluations to assess depression, suicidal ideation, and side effects.

NCT ID: NCT05795361 Available - Hunter Syndrome Clinical Trials

Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

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

As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies will be closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued treatment with idursulfase-IT remains positive.

NCT ID: NCT05844436 Available - HSV Clinical Trials

Expanded Access Intermediate Size Treatment Protocol: Pritelivir for Immunocompromised Subjects With Treatment Resistant Herpes Simplex Virus Type 1 or 2

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

AiCuris Anti-infective Cures AG (AiCuris) is developing pritelivir for the oral treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infections in immunocompromised subjects. The purpose of the expanded access program (EAP) is to provide pritelivir to immunocompromised subjects with treatment resistant HSV type 1 or 2 who cannot participate in a clinical trial and for whom no approved treatment option is available. In view of the available pre-clinical and clinical data for pritelivir in immunocompromised subjects with treatment resistant HSV, the lack of treatment options, and the demand for compassionate use of pritelivir, AiCuris aims to provide access to pritelivir via this expanded access program (intermediate size treatment protocol) in the USA. The patient population is focused on those immunocompromised subjects that are not responding to the available FDA-approved antiviral options or cannot use these because of an underlying medical condition. This EAP enables pritelivir to be available as a treatment option for immunocompromised subjects with treatment-resistant HSV type 1 or 2, who do not have access to clinical trial options.

NCT ID: NCT05897294 Available - Clinical trials for Invasive Pulmonary Aspergillosis

Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis

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

Voriconazole Inhalation Powder is available on an expanded access basis to patients with pulmonary aspergillosis for up to 12 weeks. Duration of treatment may be extended on a case-by-case basis depending on drug availability and after discussion with the Sponsor.

NCT ID: NCT05906706 Available - Bullous Pemphigoid Clinical Trials

Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

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

The objective of the program is to provide patients with Bullous Pemphigoid (BP), that participated in the R668-BP-1902 (NCT04206553) phase 2/3 study, dupilumab treatment and evaluate the long-term safety of dupilumab.

NCT ID: NCT05911399 Available - Clinical trials for Allan-Herndon-Dudley Syndrome

Expanded Access Program for Tiratricol in Patients With Monocarboxylate Transporter 8 Deficiency

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

The goal of this program is to provide expanded access (i.e., before marketing authorization) to tiratricol as treatment for patients with monocarboxylate transporter 8 deficiency (MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome [AHDS]), who in their Treating Physician's opinion, could benefit from tiratricol and meet the eligibility criteria.