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Clinical Trials

Idiopathic Pulmonary Fibrosis Prospective Outcomes Registry (IPF-PRO)

The registry is a prospective registry that will collect information regarding the natural history, healthcare interactions, participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis established at enrolling subspecialty care center. In addition, blood samples will be collected and banked for future research projects.

 

BI 1199.214:  A double blind, randomized, placebo-controlled trial evaluating efficacy and safety of oral nintedanib, 150mg twice daily for 52 weeks in patients with Systemic Sclerosis associated interstitial lung disease.

The objective of this trial is to assess the efficacy and safety of Nintedanib in the treatment of Systemic Sclerosis with Interstitial Lung Disease at a dose of 150mg twice a day compared to placebo. The primary objective is to demonstrate a reduction in the annual rate of decline in lung function over 52 weeks in the nintedanib treatment group compared to placebo group.

 

Genome research in African American Scleroderma Patients (GRASP)

Systemic sclerosis (SSc) is an autoimmune disease with unknown cause that effects many organ systems and may cause death.  Previous investigations into understanding the  genetic basis of the disease have provided important information on how to predict which patients will have higher risk of which type of organs (heart, lung, etc) organ involvement. However, most studies have focused on caucasian patients of European descent. This is problematic in understanding the disease because, patients of African descent have a more severe and rapid disease course with a higher mortality.  An improved understanding of genetic background and disease course in this population will help physicians identify important insights into factors predicting risk of death and treatment that can improve survival and health in these patients.  


The Natural History and Outcome of Scleroderma Patients at High Risk or with Early Pulmonary Hypertension

The primary objective of this study will be two pronged.

To determine the timeline of progression from pre-pulmonary hypertension to diagnosable pulmonary hypertension based on right heart catheterization. 

To determine the timeline for progression from diagnosable pulmonary hypertension to clinical worsening of disease as defined as death, hospitalization, or worsening of PHT symptoms as defined below.

 

PS-G201: A Phase 2, randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of P-1037 Solution for Inhalation in Patients with Cystic Fibrosis (CF) Clean-CF (Clearing Lungs with EnAciNhibition in Cystic Fibrosis)

The goal of the study is to evaluate the safety and tolerability of P-1037 and to determine whether the combination of P-1037 with hypertonic saline or P-1037 alone has a greater effect on lung function in patients with CF than placebo (0.17% saline). The study plans to enroll about 144 subjects in the United States and about 15 subjects at this site. Participation in this study will last approximately 6 weeks and will include 4 study visits to the study center and 4 telephone calls, texts, or e-mails from the study staff.

 

VX14-661-107: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)

This objective of the study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor in subjects with CF. The study plans to enroll about 300 people with CF across the United States and in other countries, and about 10 people at this site.

Participation could last for approximately 20 weeks. This will include a screening period that will last up to 4 weeks, a Treatment period that will last up to 12 weeks, and if needed, a Safety Follow-Up Visit that will take place 4 weeks after your last dose of Study Drug.



VX14-661-110: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

To objective of the study is to evaluate the long-term safety and tolerability of VX-661 in combination with ivacaftor in subjects with CF, who participated in the Vertex parent study VX14-661-107.  The roll over study plans to enroll about 300 subjects with CF across the United States and in other countries, and about 10 people at this site who previously participated in the VX14-661-107. Participation could last for approximately 100 weeks. This will include a treatment period that will last up to about 96 weeks, and a safety follow-up visit about 4 weeks after the Week 96 Visit.  


Cystic Fibrosis Patient Registry:

The CF Patient Registry is an observational study that serves as an epidemiologic record of demographics, characteristics of disease and treatment, utilization patterns, and clinical outcomes. Since 1985, a registry of patients with CF seen at all Cystic Fibrosis Foundation-accredited care centers has been maintained and updated on an ongoing basis by the Cystic Fibrosis Foundation.   All patients diagnosed with CF and CF related disorders (e.g. CFTR-related metabolic syndrome, CFTR-related disorder) that are seen at Tulane Medical Center are eligible for the CF Patient Registry.

 

For further information contact: Sandy Ditta @ (504) 988-4040 or email: sditta@tulane.edu

 

1430 Tulane Ave, New Orleans, LA 70112 504-988-2250 website@tulane.edu