(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation (MAVERIC)
Status: Not yet recruiting
Location: Cleveland Clinic, Massachusetts General Hospital, Mayo Clinic in Rochester, Northwestern University Medicine, University of Virginia
Conditions: Cleveland Clinic, Massachusetts General Hospital, Mayo Clinic in Rochester, Northwestern University Medicine, University of Virginia
City/State:
Chicago, Illinois
Boston, Massachusetts
Rochester, Minnesota
Cleveland, Ohio
Charlottesville, Virginia
Contact Information:
Name: Andrea B Parker, MSc., PhD
Phone Number: +1 289 910 0862
Email: [email protected]
Name: Heather Dalgleish, MSc.
Phone Number:+1 289 910 0384
Email: [email protected]
Brief Summary: Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation.
Double-blind treatment will be initiated 10 – 14 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.
The objective is to assess whether patients who discontinue therapy with an IL-1 blocker for recurrent pericarditis remain free of pericarditis recurrence while receiving CardiolRx.
Detailed Description: Double-blind, randomised, placebo-controlled Phase-3 trial. The primary objective is to assess whether patients with IL-1 blocker-dependent recurrent pericarditis can discontinue IL-1 blocker therapy and remain free of recurrence while receiving CardiolRx.
After informed consent is obtained, patients will be screened for eligibility. Baseline assessments will be performed during screening within 7 days of Day 1 (Visit 1) and include the following: Physical examination, vital signs, highest NRS pain score within the past 7 days of Day 1, 12-lead ECG; hematology (CBC with differential) and blood chemistry (including complete metabolic panel: sodium, potassium, calcium, glucose, ALT/AST, bilirubin, alkaline phosphatase, blood urea nitrogen (BUN), creatinine/eGFR), C-SSRS and a pregnancy test for women of childbearing potential.
Eligible patients will be randomized on Day 1 to either CardiolRx or matching placebo. Double-blind trial therapy will be initiated in the evening of Day 1, 10 – 14 days prior to the last scheduled dose of the IL-1 blocker and after all baseline assessments are completed. Trial therapy will be administered for 24 weeks.
Final efficacy assessments will take place 24 weeks after starting trial therapy and include a physical exam, vital signs, pain score NRS, a 12-lead ECG, as well as laboratory assessments (including a pregnancy test in women of childbearing potential) and a C-SSRS.
A safety follow-up visit will be scheduled 4 weeks after the last trial therapy administration.
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Status: Recruiting
Location: Boston Children's Hospital, Children's Healthcare of Atlanta - Egleston, Children's Hospital & Clinics of Minn, Children's Hospital - New Orleans, Children's Hospital Los Angeles, Children's Hospital of Colorado, Children's Hospital of Michigan, Children's Hospital of Philadelphia, Children's Mercy - Kansas City, Children's Minnesota, Children's National Hospital- Washington D.C., Children's of Alabama - Birmingham, Cincinnati Children's Hospital Medical Center, Columbia University Medical Center, Connecticut Children's Medical Center, Duke University Medical Center, FL, Indiana University, Indiana University School of Medicine, Lucile Packard Children's Hospital Stanford, Lurie Children's Hospital, Medical University of South Carolina (Musc) - Childrens Hospital, Nemours Children's Hospital Delaware, Northwell Health- Cohen Children's Medical Center, Phoenix Children's Hospital, Portland, Primary Children's - Salt Lake City, Seattle Children's Hospital, Seattle Children's Hospital & Research Institute, Texas Children's Hospital, The Hospital for Sick Children Toronto, UPMC Children's Hospital of Pittsburgh, University of Michigan Hospital-Mott Children's Hospital, Valley Children's Hospital, Washington University School of Medicine
Conditions: Boston Children's Hospital, Children's Healthcare of Atlanta - Egleston, Children's Hospital & Clinics of Minn, Children's Hospital - New Orleans, Children's Hospital Los Angeles, Children's Hospital of Colorado, Children's Hospital of Michigan, Children's Hospital of Philadelphia, Children's Mercy - Kansas City, Children's Minnesota, Children's National Hospital- Washington D.C., Children's of Alabama - Birmingham, Cincinnati Children's Hospital Medical Center, Columbia University Medical Center, Connecticut Children's Medical Center, Duke University Medical Center, FL, Indiana University, Indiana University School of Medicine, Lucile Packard Children's Hospital Stanford, Lurie Children's Hospital, Medical University of South Carolina (Musc) - Childrens Hospital, Nemours Children's Hospital Delaware, Northwell Health- Cohen Children's Medical Center, Phoenix Children's Hospital, Portland, Primary Children's - Salt Lake City, Seattle Children's Hospital, Seattle Children's Hospital & Research Institute, Texas Children's Hospital, The Hospital for Sick Children Toronto, UPMC Children's Hospital of Pittsburgh, University of Michigan Hospital-Mott Children's Hospital, Valley Children's Hospital, Washington University School of Medicine
City/State:
Birmingham, Alabama
Phoenix, Arizona
Los Angeles, California
Madera, California
Palo Alto, California
Aurora, Colorado
Harford, Connecticut
Wilmington, Delaware
Washington, DC
Hollywood, Florida
Atlanta, Georgia
Chicago, Illinois
Indianapolis, Indiana
New Orleans, Louisiana
Boston, Massachusetts
Ann Arbor, Michigan
Detroit, Michigan
Minneapolis, Minnesota
Kansas City, Missouri
Saint Louis, Missouri
New Hyde Park, New York
New York, New York
Durham, North Carolina
Cincinatti, Ohio
Portland, Oregon
Philadelphia, Pennsylvania
Pittsburgh, Pennsylvania
Charleston, South Carolina
Houston, Texas
Salt Lake City, Utah
Seattle, Washington
Toronto, Ontario
Contact Information:
Pfizer CT.gov Call Center
(800) 718-1021
email: [email protected]
Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who:
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- Are age <21 years.
- Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 7 days of symptom onset.
- Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
- Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.
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This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.
Detailed Description:
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.
To be classified as having COMIRNATY-associated myocarditis/pericarditis, a person must 1) meet the CDC case definition for probable or confirmed myocarditis/pericarditis, 2) have received any dose of COMIRNATY ≤ 7 days of symptom onset, and 3) have no other plausible alternative etiology at the time of enrollment.
To be classified as having myocarditis/pericarditis associated with COVID-19, a person must have 1) either acute severe COVID-19 infection or MIS-C, as defined by the CDC, 2) findings of probable or confirmed myocarditis in the CDC definition, 3) no other plausible alternative etiology. A description of the three cohorts is as follows:
Cohort 1: Prospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled under protocol during hospitalization or </= 2 weeks of hospital discharge.
Cohort 2: Retrospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled > 2 weeks after hospital discharge. Participants can be retrospectively ascertained and enrolled at any time from their COMIRNATY-associated myocarditis/pericarditis.
Cohort 3: Comparator cohort of COVID-19- related myocarditis/pericarditis , including MIS-C, both retrospectively and prospectively ascertained, and enrolled at any time from their COVID-19 or MIS-C associated myocarditis/pericarditis diagnosis.
Participants in all cohorts will be those who present to participating medical centers for care. This study is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI)’s Pediatric Heart Network (PHN) and Pfizer.
Enrollment will include approximately 300 prospectively and retrospectively ascertained cases of children, adolescents, and young adults <21 years of age who receive care for myocarditis/pericarditis associated with COMIRNATY (Cohort 1 and 2); and approximately 100 persons <21 years of age with COVID -19-associated myocarditis/pericarditis, including MIS-C (Cohort 3).
Read moreREgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients (Resonance)
Status: Recruiting
Location: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cedars-Sinai Medical Center, Children's National Hospital- Washington D.C., Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Detroit Medical Center, Houston Methodist Hospital, Johns Hopkins University, Lender Research Center at the Christ Hospital, Massachusetts General Hospital, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Northwestern University Medicine, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, Swedish Medical Center - Cherry Hill, TKL Research Inc., University of California - San Diego, University of Texas Southwestern, University of Utah, University of Vermont Medical Center, Virginia Commonwealth University
Conditions: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cedars-Sinai Medical Center, Children's National Hospital- Washington D.C., Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Detroit Medical Center, Houston Methodist Hospital, Johns Hopkins University, Lender Research Center at the Christ Hospital, Massachusetts General Hospital, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Northwestern University Medicine, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, Swedish Medical Center - Cherry Hill, TKL Research Inc., University of California - San Diego, University of Texas Southwestern, University of Utah, University of Vermont Medical Center, Virginia Commonwealth University
City/State:
Anchorage, Alaska
Tucson, Arizona
La Jolla, California
San Diego
Davenport, Iowa
Baltimore, Maryland
Boston, Massachusetts
Minneapolis, Minnesota
Rochester, Minnesota
Saint Louis, Missouri
Fair Lawn, New Jersey
New York, New York
Cincinnati, Ohio
Cleveland, Ohio
Pittsburgh, Pennsylvania
Houston, Texas
Burlington, Vermont
Richmond, Virginia
Seattle, Washington
Los Angeles, California
Washington, D.C.
Chicago, Illinois
Detroit, Michigan
Dallas, Texas
Salt Lake City, Utah
Contact Information:
JoAnn Clair, PhD
781 431 9100
[email protected]
Brief Summary:
The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.
Efficacy and Safety of RPH-104 Treatment in Patients With Recurrent Pericarditis
Status: Not yet recruiting
Location: Virginia Commonwealth University
Conditions: Virginia Commonwealth University
City/State:
Richmond, Virginia
Contact Information:
Antonio Abbate, MD
804-828-0513
[email protected]
Brief Summary:
The primary purpose of this study is the evaluation of the efficacy and safety of RPH-104 treatment in patients with recurrent pericarditis.
Pharmacokinetic and pharmacodynamic parameters of RPH-104 multiple doses in this patient population will be assessed as well.
Detailed Description:
This is a phase 2/3 seamless design study with one interim efficacy analysis. At stage 1 (assuming possible 10% dropout rate in run-in period and screening), around 25 patients will be enrolled. At least 20 patients will be randomized to receive either RPH-104 treatment or placebo.
During the interim analysis, the enrollment won’t be paused. Based on interim analysis results the study could be continued or closed. In the case of study continuation, the final estimated sample size is at least 72 patients to be randomized in the withdrawal period (including 20 or more patients randomized in the Stage 1 of the study). Assuming possible 10% dropout in run-in period and 45% dropout in screening period, approximately enrollment of 80 subjects are planned and around 146 subjects will be screened in this study.
The study will consists of five following periods:
- Screening period (up to 4 weeks). The patients’ eligibility for the study will be evaluated based on the eligibility criteria.
- Run-in (RI) single-blind treatment period (16 weeks) will include single- blind treatment with RPH-104 at a dose 160 mg subcutaneous (SC) on Day 0, and 80 mg on Day 7, Day 14 and thereafter once in two weeks (Q2W) for all patients.
The RI period includes:
- 2-weeks Stabilization period, during which blinded RPH-104 is administered on top of standard of care (SOC) pericarditis therapy, and the ongoing pericarditis episode is treated.
- 10- week Weaning period, during which patients are gradually tapered and stopped background SOC pericarditis therapy, while treatment with blinded RPH-104 continues. corticosteroids (CS) and analgesics (opioid and non-opioid) dose will be tapered starting at RI week 2 and will be stopped by Week 12. NSAIDs and colchicine will be tapered starting at RI Week 6 and will be stopped by Week 12. Opioid analgesics can be continued after Week 12 at stable doses through the end of the OL period if cannot be discontinued without withdrawal symptoms.
- 4-week Monotherapy period: patients who stopped of background SOC pericarditis therapy will continue to receive blinded RPH-104.
Patients who discontinue SOC therapy and achieve clinical response at Week 16 are eligible for randomization in the randomized withdrawal (RW) period.
- Randomized withdrawal (RW) period (24 weeks) includes double-blind treatment with RPH-104 80 mg or placebo Q2W depending on the randomization group.
- Open-label treatment period (OL) (12 weeks). After completion of the RW period, all subjects that did not discontinue study drug will be transferred to Open-Label (OL) period and will receive open-label RPH-104 80 mg once in two weeks.
- Safety follow-up period includes monitoring of safety for 8 weeks after the last dosing of the study drug for patients who decided not to participate in open label extension long-term safety study (CL04018108).
The total maximal duration of the study for an individual subject will be approximately 64 weeks.