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NCT ID: NCT04323761 Approved for marketing - SARS-CoV2 Infection Clinical Trials

Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection (COVID-19)

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

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

NCT ID: NCT03070093 Approved for marketing - Clinical trials for Acute Myeloid Leukemia (AML)

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

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

The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery [CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to comparable or alternative therapy.

NCT ID: NCT01764191 Approved for marketing - Cardiac Sarcoidosis Clinical Trials

18F-FDG PET Imaging in Cardiac Sarcoidosis

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

This study has been designed to provide patients suspected of having cardiac sarcoidosis (CS) with a potentially diagnostic 18F FDG PET/CT. CS is difficult to diagnose with currently available methods, therefore this project will allow access to 18F FDG PET/CT scanning, which may more accurately diagnose the presence of CS. This study will also provide additional data to further examine the effectiveness and safety profile of 18F FDG for this condition. Accurate and early detection is important to allow for better management of CS and improve patient care. The purpose of this study is to provide access to 18F-FDG PET/CT imaging in patients with clinical suspicion of cardiac sarcoidosis, and to collect additional data about the safety and effectiveness of 18F-FDG PET/CT in this patient population

NCT ID: NCT01632826 Approved for marketing - Multiple Myeloma Clinical Trials

Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

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

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available

NCT ID: NCT01240421 Approved for marketing - Clinical trials for Metastatic Breast Cancer

An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory

Start date: March 2011
Phase: N/A
Study type: Expanded Access

This expanded access program is an open-label, multi-center study, which will consist of a PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria will be treated. The program will continue in each country until eribulin is approved, reimbursed and launched in that country, or termination of the program by the Sponsor.

NCT ID: NCT01217697 Approved for marketing - Clinical trials for Urogenital Neoplasms

Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

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

The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

NCT ID: NCT00989807 Approved for marketing - Cystic Fibrosis Clinical Trials

Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis

EAP
Start date: n/a
Phase: N/A
Study type: Expanded Access

This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.

NCT ID: NCT00933205 Approved for marketing - HIV Infections Clinical Trials

An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

Start date: May 2004
Phase: N/A
Study type: Expanded Access

The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.

NCT ID: NCT00338247 Approved for marketing - Neoplasms, Breast Clinical Trials

EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

Start date: July 2006
Phase: Phase 4
Study type: Expanded Access

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

NCT ID: NCT00245739 Approved for marketing - HIV Infections Clinical Trials

TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

The purpose of this study is to provide early access to TMC114 (a protease inhibitor) for HIV-1 infected patients with limited or no treatment options, who have failed multiple antiretroviral (ARV) regimens, and to evaluate the longer-term safety and tolerability of TMC114/r in combination with other antiretrovirals