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NCT ID: NCT05541289 No longer available - COVID-19 Clinical Trials

Expanded Access Program of Whole, Inactivated COVID-19 Vaccine COVAXIN™ (BBV152) in Adults Aged 18 Years and Older

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

This Expanded Access, Phase 3, open label study is intended to provide access to COVAXIN™ (BBV152) to individuals who are at risk or have predisposing conditions that can lead to complications with the current immunization options against SAR-CoV-2 Virus infection.

NCT ID: NCT05505838 No longer available - Clinical trials for Transthyretin-mediated Amyloidosis With Cardiomyopathy

Expanded Access Protocol to Provide Patisiran to Patients With Transthyretin-mediated Amyloidosis With Cardiomyopathy

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

The objective of the study is to assess the long-term safety of patisiran in patients with ATTR amyloidosis with cardiomyopathy as assessed by a review of adverse events (AEs).

NCT ID: NCT05398640 No longer available - Metastatic Melanoma Clinical Trials

Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma

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

This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.

NCT ID: NCT05392374 No longer available - Glioma Clinical Trials

Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas

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

This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials.

NCT ID: NCT05317780 No longer available - Canavan Disease Clinical Trials

Canavan-Single Patient IND

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

A recombinant virus vector constructed from adeno-associated virus (AAV) has been engineered to carry the human aspartoacylase (ASPA) gene expressed from a modified CMV-enhancer chicken β-actin (CB6) promoter. The construct has been shown to produce ASPA in animal models of Canavan disease, which closely match the proposed human study. The proposed clinical trial is an open label, expanded access study administering rAAV9-CB6-AspA gene vector by simultaneous systemic and intracerebroventricular routes to a single human subject (18-24 months of age) with Canavan disease. The subject will also receive immune modulation to transiently ablate B-cells (Rituximab) and modulate T-cell response (Sirolimus) prior to the initial exposure to AAV9. Given the null AspA mutations of the subject and current AAV seronegative status, this regimen will allow for later exposure to the therapeutic vector if needed and block any immuno-toxicity in the CNS. The goal of this study is to measure the safety and efficacy of AAV-mediated gene therapy as a treatment approach for neuronal pathology in Canavan disease. The subject will act as their own control and change from baseline will be assessed in regards to levels of brain NAA, brain water content and morphology, improved clinical status and peripheral levels of NAA. Safety parameters measured in this study will include: serum chemistries and hematology, urinalysis, physical assessments, whole blood assay for vector genomes, immunologic response to ASPA and AAV, as well as reported subject symptom history.

NCT ID: NCT05235347 No longer available - Covid19 Clinical Trials

Sotrovimab Expanded Access Treatment Protocol (COVID-19)

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

An expanded access program for sotrovimab administered intravenously to participants with COVID-19 illness who meet current authorized/approved criteria for use of sotrovimab.

NCT ID: NCT05154851 No longer available - Clinical trials for Congenital Muscular Dystrophy Due to Lamin A/C Mutation

HBCMD01- Expanded Access for the Treatment of Congenital Muscular Dystrophy.

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

This individual patient expanded access IND is requested for a patient diagnosed with LMNA-related congenital muscular dystrophy (L-CMD). In this expanded access, the patient will receive the investigational product through 14 intravenous infusions, followed by Follow-Up visit and an End of Study.

NCT ID: NCT05131438 No longer available - Clinical trials for Extranodal NK/T-cell Lymphoma

An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (R/R ENKTL)

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

This program is intended to provide access to sugemalimab for participants with R/R ENKTL, after their disease failed to respond to prior treatment regimen(s), preceding marketing authorization by the local regulatory agency.

NCT ID: NCT05086094 No longer available - Clinical trials for Multiple System Atrophy (MSA)

Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)

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

The purpose of this expanded access program is to provide access to the investigational drug verdiperstat in patients with Multiple System Atrophy (MSA). Expanded access allows patients with a serious or a life-threatening disease or condition access to an investigational drug when no satisfactory approved treatment options are available.

NCT ID: NCT05002465 No longer available - Prostate Cancer Clinical Trials

Clinical Use of 68Ga PSMA-11 PET/CT in Diagnosing, Staging and Restaging Prostate Cancer

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

The purpose of this protocol is to provide 68Ga Prostate Specific Membrane Antigen-11 (68Ga PSMA-11) for clinical use in the diagnosis, staging and restaging of prostate cancer using Positron Emission Tomography with Computed Tomography (PET/CT) prior to its full local Federal Drug Administration (FDA) approval. Extensive research has shown that 68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care usually used in staging and restaging prostate cancer.