A Randomized, Open-label, Phase 2 Study of Sipuleucel-T With Concurrent Versus Sequential Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
This is a randomized, open-label study designed to assess the effects of sipuleucel-T when
administered concurrently or sequentially with enzalutamide. This study consists of 3 phases.
The screening phase will begin at the completion of the informed consent process and continue
through registration. The active phase will begin at registration and continue through the
post-treatment visit (30 to 37 days following the last study treatment). The long term
follow-up (LTFU) phase will begin after the post-treatment visit and will continue until the
subject's death or until Dendreon terminates the study.
Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
The purpose of this study is to evaluate the safety and effectiveness of the leadless
pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The
Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in
battery and electrodes, for permanent implantation in the right ventricle. As a leadless
pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has
the same operating principles as a conventional pacemaker.
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for
use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV
symptoms.
The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational
study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal
medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not
dependent on intravenous inotropic support and who meet the FDA approved indications for HM
II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD.
Together with the investigator, the subjects will decide which cohort to enter into at their
baseline visit. This study will include experienced HM II LVAD implant centers as well as
community centers that care for a large volume of heart failure patients. Study patients will
be followed for up to 24 months post enrollment for survival, quality of life and functional
status.
A Multicenter, Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment with Cimzia
This is a multicenter prospective study evaluating the placental transfer of certolizumab pegol (CZP) by measuring concentration of CZP in infants born to mothers who are on this drug during pregnancy. Certolizumab is a drug that is approved for use in Crohn's disease, rheumatoid arthritis and ankylosing spondylitis. Recent evidence suggests that certolizumab pegol does not cross the placenta, unlike other anti-tumor necrosis factor drugs. The primary objective of this study is to assess whether there is transfer of CZP across theplacenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants. Blood samples will be measured in the infant, mother, and umbilical cord at birth. Additionally, blood samples will be collected from the infant at Week 4 and Week 8 after birth in order to assess the pharmacokinetics (PK) of CZP in infants after birth. The secondary and exploratory objectives are to assess the concentrations of CZP, anti-CZPantibodies, and polyethylene glycol (PEG) in the 3 sources of blood samples at the time of birth(infant, mother, and umbilical cord) and in the infants at 4 weeks and 8 weeks after birth. Although this study is noninterventional regarding treatment with CZP, it is consideredinterventional due to the collection of blood samples that are not part of routine clinical practice.The study will only include pregnant women who have decided to continue or start treatment withCZP for an approved indication in accordance with their treating physician prior to beingrecruited into the study. Approximately 30 pregnant subjects are planned to be screened in order to enroll 20 subjects (blood samples provided by the mother and infant at delivery/birth). To beeligible to participate in the study, subjects must be 30 weeks pregnant at the start of screening,and expecting to use CZP within 35 days prior to expected delivery date. The primary PK variable is plasma concentration of CZP in the infant at birth. Secondary andexploratory variables include plasma concentrations of CZP, anti-CZP antibodies, and PEG. In addition, safety variables are adverse events (AEs) which will be assessed by a Safety Follow-up phone assessment for mother and infant performed 5 weeks (5 days) after the final sample is obtained. Subjects who withdraw prematurely will have a Safety Follow-Up telephone contact (for mother and infant) 5 weeks (5 days) after withdrawing from the study.
A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
The study consists of three phases: Prerandomization, Randomization (Core Study) and
Extension Phase. Participants 18 years of age and over, who meet all the eligibility
requirements will be randomized into the study. It will require that splenectomized
participants make up at least 35% of the study population and no single platelet count is
greater than 35x10^9/L. Participants will be centrally stratified at randomization by
splenectomy status, baseline platelet count, and use of concomitant ITP medication at
baseline and randomized to receive either double-blind avatrombopag or eltrombopag in a 1:1
ratio. Participants will receive blinded therapy at a starting dose of 20 mg avatrombopag
once daily or 50 mg eltrombopag once daily. Participants will be allowed to have their dose
titrated up (maximum dose 40 mg avatrombopag and 75 mg for eltrombopag) or down (minimum dose
5 mg for avatrombopag and 25 mg for eltrombopag) depending on their response to study drug.
The goal of dose modification is to maintain the platelet count at levels greater than or
equal to 50x10^9/L and less than or equal to 150x10^9/L, and to decrease the need for
ITP-directed concomitant medications. The duration of treatment in the Core study and the
Extension Phase is approximately 26 and 104 weeks, respectively.
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