PAH QuERI Extension Program – Principal Investigator: Dr. Rehman - 9 patients enrolled
Description: This is a prospective, U.S.-based, multi-center, knowledge translation program tracking patient management over the course of 3 years. The objective of this program is to improve the management of PAH patients through an evidence-based approach aimed at achieving optimal World Health Organization (WHO) functional class (FC) defined as: 1) improvement of FC III or IV to FC II; 2) improvement of FC II to FC I; or 3) maintaining FC II or I. Eligible patients who agree to participate and sign the informed consent will be treated by their physician with a goal of achieving optimal care, as dictated by their standard of care and individual patient's care needs. Information on treatment will be captured at least every 6 months (±2 months) using the Remote Data Entry Platform. All patients will be assessed for: vital signs (blood pressure and heart rate), WHO functional class, and PAH specific and other treatment(s) documented, as part of routine patient care. Patients will be prescribed commercially available medications by their physicians according to a treatment strategy which they believe is in the best interest of their patient. Approximately 800 PAH patients from approximately 80 physician practices will be included in the program. Locally, we anticipate enrolling 10 patients with the possibility of enrolling additional patients with the written approval by the sponsor.
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects with Uncontrolled, Persistent Asthma – Principal Investigator: Dr. Butt - Currently awaiting IRB approval (possibly will make the June 26th meeting)
Description: This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept (POC) study designed to assess the safety and efficacy of JNJ-38518168 which is orally administered to subjects with uncontrolled, eosinophilic, persistent asthma that is inadequately controlled despite current therapy. A total of 160 subjects will be randomized (approximately 80 subjects per group). Subjects are randomly assigned in a 1:1 ratio to receive either placebo or 30 mg of the investigational study agent, JNJ-38518168, once daily through week 24. We anticipate on enrolling approximately 10 subjects locally at ECU.
The study will enroll asthmatic subjects who remain uncontrolled on standard of care (ICS ± LABA ± montelukast). The study will be approximately 32 weeks in duration which is comprised of a screening phase of approximately 4 weeks, a 24-week placebo-controlled treatment phase, and a 4-week follow-up phase. The end of the study is defined as the last follow-up visit of the last subject.
The primary objective is to assess the efficacy (as measured by the change from baseline in prebronchodilator percent-predicted forced expiratory volume in 1 second [FEV1]) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment. In addition, the secondary objectives are to assess the safety, efficacy (as measured by improvement in asthma control), tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in subjects with eosinophilic persistent asthma that is inadequately controlled despite current treatment.
The primary hypothesis is that JNJ-38518168 is superior to placebo as measured by the change from baseline in pre-bronchodilator percent-predicted FEV1 at Week 16 in subjects with uncontrolled, eosinophilic, persistent asthma who are inadequately controlled despite current treatment (ICS ± LABA ± montelukast).
Clinical Outcomes Study in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD). Principal Investigator – Dr. Bowling. IRB Meeting on June 12th
Description: The purpose of this research study is to test the long term effects of fluticasone furoate and vilanterol combination in comparison to fluticasone furoate (FF) alone (a drug approved by the FDA to reduce symptoms of nasal allergies by reducing inflammation), vilanterol (VI) alone (an investigational drug that can relax muscles around the air passages, allowing them to open up) and placebo (inactive substance which looks the same as the active medicine, but contains no active drug) in reducing pulmonary and cardiovascular complications, including death, in subjects with COPD. By doing this research, we hope to learn the effectiveness of these medications in the long term treatment of COPD.
The primary objective of this study is to prospectively evaluate the effect of Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25mcg QD compared with placebo on survival in subjects with moderate COPD (≥50 and ≤70 % predicted FEV1) and a history of, or at increased risk for developing, cardiovascular disease.
This is a randomized, double-blind, parallel-group, multi-center, placebo-controlled study to evaluate the long term efficacy and safety of FF/VI Inhalation powder 100/25mcg QD, FF Inhalation powder 100mcg QD and VI Inhalation powder 25mcg QD when administered via the Novel Dry Powder Inhaler. Once daily dosing will occur in the morning (with the exception of the first treatment visit).
The target enrolment is approximately 16,000 randomized subjects at approximately 1100 study centers globally. We plan to enroll approximately 20 patients locally at our site. Based on current assumptions of the event rate, the total duration of subject participation will be approximately between 15 and 44 months, consisting of a 4-10 day run-in period, variable treatment period and a 1-week follow-up period. Subjects will be randomized to treatment after a 4-10 day run-in period. Prior to the Run-in period, subjects will discontinue the use of specific COPD medications.
A RANDOMIZED, OPEN-LABEL, MULTICENTER, CONTROLLED STUDY TO ASSESS SAFETY AND EFFICACY OF ELAD® IN SUBJECTS WITH ALCOHOLINDUCED LIVER DECOMPENSATION (AILD) – Principal Investigator: Dr. McCarthy - Awaiting ancillary committee review
Description: This research is being done to determine the safety and the effectiveness (how well the system works) of the ELAD® system. The ELAD system is experimental, and it is not an approved "treatment" for any disease or medical condition.
Patients enrolled will be in the hospital and are experiencing signs and symptoms of Alcohol-Induced Liver Decompensation (AILD). AILD is a worsening of the chronic liver disease.
ELAD is designed to provide liver support continuously to a subject with liver failure, allowing time for the subject's own liver to regenerate or to stabilize. The ELAD system is similar to kidney hemodialysis (the procedure where waste products normally removed by the kidney are removed from the blood by passing the blood through a special filter in patients with kidney failure). ELAD is different than kidney dialysis in that blood will be passed through a filter separating out some of the liquid in the blood making what is called "ultrafiltrate". The ultrafiltrate is then passed through four cartridges containing live human liver cells grown in a laboratory. Once the ultrafiltrate passes through the cartridges, it is returned to the patient by the system. The liver cells in the cartridges may be able to provide some of the vital functions that a normal healthy liver performs such as the breakdown of certain waste products and harmful chemicals or toxins and the making of essential proteins, thereby possibly providing temporary liver function to the patient.
The substudy that is voluntary that is related to the study is for tracking economic data of subjects participating in the protocol VTI-208. The impact of ELAD must be assessed financially by looking at the length of hospital stay, hospital charges, and the number and costs of revisits after hospital discharge. Only those patients enrolled in the ELAD main study can participate in the substudy.
A Multi-Center, Randomized, Controlled, Pivotal Study To Assess the Safety and Efficacy of A Selective Cytopheretic Device (SCD) In Patients with Acute Kidney Injury (AKI) Principal Investigator – Dr. McCarthy
Description: This is a pivotal study that will evaluate the clinical and statistical improvement on all-cause mortality through Day 60 post randomization of Continuous Renal Replacement Therapy (CRRT) + Selective Cytopheretic Device (SCD) treatment compared to CRRT alone. To assess the effect of SCD treatment on various measures of patient clinical outcome and to evaluate the integrity of the SCD-ARF and patient safety in SCD treatments from the time of initiation of therapy to as many as seven consecutive 24-hour SCD treatments.