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Total Parenteral Nutrition-induced Cholestasis
Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin.
- Trial name
- NCT02929303
- Testing
- Omegaven IV lipid emulsion
- Where
- United States
- Sponsor
- Wake Forest University Health Sciences
KRAS G12V Mutant Advanced Epithelial Cancers
Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors
This intermediate-size IND will treat participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation and appropriate HLA class II match (HLA-DRB1*07:01).
- Trial name
- NCT05389514
- Testing
- Cyclophosphamide, Gemcitabine, Pembrolizumab
- Sponsor
- Providence Health & Services
Non-Muscle Invasive Bladder Neoplasms
Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
- Trial name
- NCT06877676
- Testing
- TAR-200
- Sponsor
- Janssen Research & Development, LLC
ALS (Amyotrophic Lateral Sclerosis)
Intermediate-size Patient Population Expanded Access Protocol
The purpose of this Expanded Access Program is to provide tazbentetol to ALS patients who are not eligible to enroll in an ALS clinical trial.
- Trial name
- NCT07088159
- Testing
- Tazbentetol
- Where
- 16 sites in United States
- Sponsor
- Spinogenix
Multiple Sclerosis
Expanded Access to Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
To give expanded access to intrathecal autologous MSC-NP treatment to patients with progressive MS who do not meet the inclusion/exclusion criteria of our Phase II stem cell trial.
- Trial name
- NCT03822858
- Testing
- Intrathecal MSC-NP injection
- Where
- United States
- Sponsor
- Tisch Multiple Sclerosis Research Center of New York
Recurrent Osteosarcoma
Single-Patient Expanded Access Protocol - RNA-LP in a Patient With Recurrent Osteosarcoma
Treatment of a patient with recurrent osteosarcoma with personalized pp65/tumor mRNA RNA-LP under an individual patient expanded access protocol.
- Trial name
- NCT07560709
- Testing
- pp65/tumor mRNA RNA-LP
- Where
- United States
- Sponsor
- University of Florida
Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.
- Trial name
- NVL-655-EAP (NCT06834074)
- Testing
- NVL-655
- Where
- 50 sites in United States, Australia and 10 more
- Sponsor
- Nuvalent Inc.
Hematologic Malignancies, Acute Myeloid Leukemia
Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies
This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS).
- Conditions
- Hematologic Malignancies, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT07346105
- Testing
- Orca-T
- Where
- 8 sites in United States
- Sponsor
- Orca Biosystems, Inc.
Advanced or Metastatic Colorectal Cancer (mCRC)
Individual Patient Expanded Access to CA102N
This study is an individual patient expanded access protocol that the subject enrolled had completed the combination treatment of CA102N plus Lonsurf for at least 12 cycles.
- Trial name
- NCT05274204
- Testing
- CA102N
- Sponsor
- Holy Stone Healthcare Co., Ltd
Treatment-Resistant Depression
NRX-101 Expanded Access
The purpose of this Expanded Access Treatment Protocol is to make NRX-101 available to patients who have treatment-resistant depression and who are unable to participate in, or do not have access to, the ongoing NRX-101 clinical…
- Trial name
- NRX-101 EAP (NCT05779267)
- Testing
- NRX-101
- Where
- United States
- Sponsor
- NeuroRx, Inc.
Gastrointestinal Neoplasms
Individual Patient Expanded Access for Velzatinib (GSK6042981) in Patients With Gastrointestinal Stromal Tumours With KIT Mutations
Compassionate Use, Individual Patient access to velzatinib (GSK6042981) for eligible patients with Gastrointestinal Stromal Tumours (GIST) who have KIT mutations and at least three prior lines of therapy
- Trial name
- NCT07825701
- Testing
- Velzatinib (GSK6042981)
- Sponsor
- GlaxoSmithKline
Epstein-Barr Virus Infection, Cytomegalovirus Infections
TETRAVI Expanded Access Program
This Expanded Access Program (EAP) allows qualified physicians within Texas to obtain access to multivirus-specific cytotoxic T lymphocytes (VSTs) developed under Baylor College of Medicine's TETRAVI program (NCT04013802) for the…
- Conditions
- Epstein-Barr Virus Infection, Cytomegalovirus Infections, Adenovirus Infection, BK Virus Infection
- Trial name
- NCT07104591
- Testing
- HLA-matched VSTs (Multivirus-specific Cytotoxic T Lymphocytes)
- Sponsor
- Baylor College of Medicine
Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter
Named Patient Program for Mitomycin for Pyelocalyceal Solution
This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named…
- Conditions
- Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Ureter, Urothelial Carcinoma Ureter Recurrent
- Trial name
- NCT05494411
- Testing
- Mitomycin for pyelocalyceal solution
- Sponsor
- UroGen Pharma Ltd.
Vascular Diseases, End Stage Renal Disease on Dialysis
Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular Disease and Dialysis Access
Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an ATEV clinical study.
- Trial name
- NCT07141641
- Testing
- Acellular Tissue Engineered Vessel (ATEV)
- Sponsor
- Humacyte, Inc.
AMG 335 Expanded Access Program for IgG4-Related Disease
Expanded access requests for AMG 335 may be considered for adult patients with a confirmed diagnosis of IgG4-related disease. To request access, use Responsible Party contact information provided in this record.
- Trial name
- NCT06590051
- Testing
- UPLIZNA
- Sponsor
- Amgen
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
- Conditions
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer
- Trial name
- NCT06443944
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 27 sites in United States
- Sponsor
- CG Oncology, Inc.
Congenital Haemophilia
Compassionate Use of Concizumab if You Have Haemophilia
The compassionate use programme will give participants concizumab for free, even though it is not yet approved by health authorities. This is because participants need this medicine to treat their haemophilia properly.
- Trial name
- NCT04921956
- Testing
- Concizumab
- Where
- 25 sites in United States, Bulgaria and 1 more
- Sponsor
- Novo Nordisk A/S
Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors
The purpose of this study is to provide the option of Ladiratuzumab Vedotin treatment to eligible patients in studies SGNLVA-005.
- Trial name
- NCT06362590
- Testing
- ladiratuzumab vedotin
- Sponsor
- Seagen Inc.
Cancer, Solid Tumor
MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer
The purpose of this Expanded Access Program (EAP) is to allow use of the investigational therapeutic agent, MNPR-101-PCTA-177Lu, for treatment of urokinase plasminogen activator receptor (uPAR)-positive solid tumors identified…
- Conditions
- Cancer, Solid Tumor, Solid Tumor Cancer, Oncology
- Trial name
- NCT06980519
- Testing
- MNPR-101-PCTA-177Lu
- Where
- United States
- Sponsor
- Monopar Therapeutics
Hereditary Angioedema
Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema
The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.
- Trial name
- NCT06415448
- Testing
- Donidalorsen
- Sponsor
- Ionis Pharmaceuticals, Inc.