
An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis...
Non-Cystic Fibrosis BronchiectasisThe purpose of this study is to allow early access to brensocatib for participants with non-cystic fibrosis bronchiectasis (NCFBE) who have successfully completed the INS1007301 ASPEN Clinical trial.

An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung...
Non-small Cell Lung CancerLung Cancer2 moreThe purpose of this study is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

An Expanded Access Program for AM0010 (Pegilodecakin)
MelanomaProstate Cancer7 moreThis is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.

Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing...
Pulmonary Arterial HypertensionIn an earlier study, sildenafil citrate administered to patients of PAH led to improvement in pulmonary arterial pressure, cardiac output, quality of life, and other parameters as compared to placebo. This protocol provides mechanism for patients who have clinical deterioration on other PAH approved therapies to have access to sildenafil prior to marketing authorization in India.

Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil
Pulmonary Arterial HypertensionThe purpose of this study is to provide sildenafil therapy to patients who completed the A1481244 study for the treatment of PAH, and reside in Brazilian States where Revatio™ is not supplied by Health Secretary, and are judged by the Investigator to derive clinical benefit from continued treatment with Sildenafil. It will be supplied until patient gets access to Sildenafil through Brazilian State Health Secretary from where patient resides.

Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
Lung TransplantCurrently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative...
Lung DiseasesInterstitialThis Expanded Access Program is intended to facilitate the availability of OFEV to patients suffering from non Idiopathic Pulmonary Fibrosis-Interstitial Lung Disease (non IPF-ILD) with a progressive clinical course despite Standard of Care treatment and for whom no satisfactory authorised alternative therapy exists or who cannot enter a clinical trial.

Expanded Access to Ensartinib for Participants With ALK+ NSCLC
Non-Small Cell Lung CancerALK Gene Rearrangement PositiveThis is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).

Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and...
Cystic FibrosisTo provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719). To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of age and older, homozygous for F508del.

Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute...
Acute-graft-versus-host DiseaseSteroid Refractory Acute Graft Versus Host Disease6 moreAn Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation. This Program is available for female and male who are recipients of allogenic HSCT and who have been newly diagnosed with acute GvHD.