Clinical trials: Access Complication
- Condition Access Complication
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia
Expanded Access to Burosumab
Individual patient expanded access requests may be considered for patients who have no other treatment options
- Trial name
- NCT03775187
- Testing
- Burosumab
- Sponsor
- Kyowa Kirin Co., Ltd.
Carcinoma, Renal Cell
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program
This study is an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or…
- Trial name
- NCT01412671
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- Japan
- Volunteers
- 117 people
- Sponsor
- Bayer
Chronic Kidney Diseases, Alport Syndrome
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with…
- Conditions
- Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney
- Trial name
- EAGLE (NCT03749447)
- Testing
- Bardoxolone methyl
- Where
- 87 sites in United States, Australia and 4 more
- Volunteers
- 270 people
- Sponsor
- Biogen
Still's Disease, Including SJIA and AOSD, With MAS or ILD Complications
Managed Access Programs for MAS825, Arumakimig
The purpose of this registration is to list Managed Access Programs (MAPs) related to MAS825, arumakimig
- Trial name
- NCT07889310
- Testing
- Arumakimig
- Sponsor
- Novartis Pharmaceuticals
Vascular Access Complication
Effectiveness of the Rapid Intravascular Start (RIVS) System Versus Conventional Catheter
The study will test a hypothesis that the RIVS system will have a higher rate of successful first PIV placement compared to conventional catheter without a significant increase in complications and time of procedure.
- Trial name
- NCT00914069
- Testing
- RIVS vascular access, Conventional vascular access
- Where
- 3 sites in United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
End Stage Renal Disease
HeRO Vascular Access Device Post Market Procedural Survey Protocol
Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.
- Trial name
- PPS (NCT00889291)
- Volunteers
- 77 people
- Sponsor
- Merit Medical Systems, Inc.
Colorectal Cancer (CRC), Pancreatic Cancer
Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval
This is an expanded access program (EAP) designed to provide access to Botensilimab and Balstilimab prior to drug registration by the applicable local regulatory agency.
- Conditions
- Colorectal Cancer (CRC), Pancreatic Cancer, Non-Small Cell Lung Cancer (NSCLC), Hepatocellular Carcinoma (HCC)
- Trial name
- NCT06751524
- Testing
- Botensilimab, Balstililmab
- Sponsor
- Agenus Inc.
Solid Tumor, Ewing Sarcoma
Expanded Access of Vigil in Solid Tumors
This is an expanded access study involving an investigational product named Vigil. Vigil is considered immunotherapy. Patients who participated in another clinical trial sponsored by Gradalis, and had Vigil made from their tumor…
- Conditions
- Solid Tumor, Ewing Sarcoma, Ewing's Tumor Metastatic, Ewing's Sarcoma Metastatic
- Trial name
- NCT03842865
- Testing
- Vigil
- Where
- United States
- Sponsor
- Gradalis, Inc.
Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and…
- Conditions
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Trial name
- NCT02822495
- Testing
- tabelecleucel
- Sponsor
- Atara Biotherapeutics
Multiple Myeloma, Diffuse Large B-Cell Lymphoma (DLBCL)
Karyopharm Expanded Access Program for Selinexor
KEAP is an expanded access program designed to provide selinexor to eligible participants outside of a clinical trial before the drug has been given marketing approval by the country's regulatory agency or the drug is…
- Conditions
- Multiple Myeloma, Diffuse Large B-Cell Lymphoma (DLBCL), Sarcoma, Neuroglioblastoma
- Trial name
- KEAP (NCT07215832)
- Testing
- selinexor
- Sponsor
- Karyopharm Therapeutics Inc
Pancreatic Cancer, Small Bowel Cancer
Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF…
- Conditions
- Pancreatic Cancer, Small Bowel Cancer, Colorectal Cancer, Melanoma
- Trial name
- NCT04566393
- Testing
- Ulixertinib (BVD-523)
- Where
- 26 sites in United States
- Sponsor
- xCures
Urogenital Neoplasms
Expanded Access to NanoDoce
NanOlogy may consider offering expanded access to NanoDoce for patients who do not meet the enrollment criteria of clinical trials in progress.
- Trial name
- NCT04060628
- Testing
- NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension
- Sponsor
- NanOlogy, LLC
End-stage Renal Disease
Ellipsys Vascular Access System Registry
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a…
- Trial name
- NCT03454113
- Testing
- Ellipsys Vascular Access
- Where
- 5 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Medtronic Endovascular
Glioblastoma, Squamous Cell Carcinoma
Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer patients upon request by a US licensed MD or DO.
- Conditions
- Glioblastoma, Squamous Cell Carcinoma, Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Trial name
- NCT05974410
- Testing
- AVM0703, Hydrocortisone, Proton pump inhibitor
- Sponsor
- AVM Biotechnology Inc
Primary Hyperoxaluria
Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
The purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with Primary Hyperoxaluria Type 1 (PH1),
- Trial name
- NCT04125472
- Testing
- Lumasiran
- Sponsor
- Alnylam Pharmaceuticals
Polycystic Kidney
Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease
Abdominal pain, sometimes severe, is a known symptom of polycystic kidney disease (PKD) related to the cystic expansion. This study will investigate whether the vasopressin V2 receptor antagonist lixivaptan can alleviate…
- Trial name
- NCT03717181
- Testing
- Lixivaptan
- Where
- United States
- Sponsor
- Palladio Biosciences
Urinary Tract Infections, Chronic Urinary Tract Infection
Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)
An Expanded Access Program for UROMUNE® for patients suffering from recurrent/chronic urinary tract infections of diverse etiology.
- Conditions
- Urinary Tract Infections, Chronic Urinary Tract Infection, Recurrent Urinary Tract Infection, Urinary Tract Infection Bacterial
- Trial name
- NCT04173013
- Testing
- Uromune
- Where
- 15 sites in Belgium, Czechia and 13 more
- Sponsor
- Impatients N.V. trading as myTomorrows
C3G, IC-MPGN
C3G/Primary IC-MPGN EAP
This is an Early Access Program (EAP) which will provide access to pegcetacoplan for eligible participants with C3G and Primary IC-MPGN.
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis
- Trial name
- NCT04729062
- Testing
- Pegcetacoplan
- Sponsor
- Apellis Pharmaceuticals, Inc.
Catheter Related Complication, Vascular Access Site Management
A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors
The study will collect use data of the Becton Dickinson (BD) PureHub™ Disinfecting Cap in combination with needle-free connectors, which are attached to vascular access devices (VAD).
- Conditions
- Catheter Related Complication, Vascular Access Site Management, Disinfecting Cap
- Trial name
- NCT05130762
- Testing
- BD PureHub™ Disinfecting Cap Placements: Attachments/removals
- Where
- 5 sites in Austria, Belgium and 2 more
- Volunteers
- 157 people
- Sponsor
- Becton, Dickinson and Company