Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure (UNIVERSE)

March 28, 2025 updated by: Janssen Research & Development, LLC

A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure

The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram [mg] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram [mg/kg]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Part A: This part includes a 12-day Initial PK, PD, and Safety Assessment Period. Participants in Part A will not participate in Part B. Randomization in Part B of this study will begin once the cumulative data from the Initial PK, PD, and Safety Assessment Period in Part A are deemed acceptable by the Independent Data Monitoring Committee. Part A of the study will consist of an up to 21-day Screening Period, a 12-day Initial PK, PD, and Safety Assessment Period, a 12-month Open-Label Treatment Period, and a 30-day Follow-Up phone contact. Part B: Participants will be randomly assigned to two treatment groups and randomization ratio will be 2:1 for rivaroxaban and ASA. ASA will be used as control. There will be an up to a 21-day Screening Period, a 12 month Open-Label Treatment Period and a 30-day Follow-Up phone contact.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Cordoba, Argentina
  • Belgium
      • Brussel, Belgium
      • Gent, Belgium
      • Leuven, Belgium
  • Brazil
      • Curitiba, Brazil
      • Porto Alegre, Brazil
      • Sao Paulo, Brazil
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Japan
      • Fukuoka, Japan
      • Kitakyushu-shi, Japan
      • Setagaya Ku, Japan
      • Shizuoka-shi, Japan
  • Malaysia
      • Kuala Lumpur, Malaysia
  • Mexico
      • Mexico, Mexico
  • Netherlands
      • Leiden, Netherlands
      • Rotterdam, Netherlands
      • Utrecht, Netherlands
  • Spain
      • A Coruña, Spain
      • Barcelona, Spain
      • Bilbao, Spain
      • Madrid, Spain
      • Valencia, Spain
  • United States
    • California
      • Los Angeles, California, United States
    • Florida
      • Gainesville, Florida, United States
    • Illinois
      • Oak Lawn, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must be considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings
  • Satisfactory initial post-Fontan transthoracic echocardiographic Screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol
  • Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements

Exclusion Criteria:

  • Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the Screening period of the study
  • History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption
  • History of or signs/symptoms suggestive of protein-losing enteropathy
  • Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding
  • Platelet count less than (<)50*10^9/Liters (L) at Screening
  • Estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2)
  • Known clinically significant liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rivaroxaban
Drug: Rivaroxaban
Participants will receive oral suspension containing rivaroxaban 1 milligram per milliliter (mg/ml) twice daily in Part A and Part B. Following total daily doses of Rivaroxaban will be administered based on the weight of the participants: 7 to <8 kilogram (kg) will receive 2.2 milligram (mg); 8 to <10 kg will receive 3.2 mg; 10 to<12 kg will receive 3.4 mg; 12 to <20 will receive 4.0 mg and 20 to <30 will receive 5.0 mg.
Experimental: Acetylsalicylic Acid
Drug: Acetylsalicylic Acid
Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)
Time Frame: Up to 12 months
Thrombotic event was defined as the appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or the occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism). The event included ischemic stroke, pulmonary embolism, venous thrombosis, arterial/intracardiac thrombosis, and other thrombosis.
Up to 12 months
Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)
Time Frame: Day 1: 0.5-1.5 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 1: 0.5-1.5 hours postdose
Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)
Time Frame: Day 1: 1.5-4 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 1: 1.5-4 hours postdose
Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)
Time Frame: Day 4: Up to 3 hours predose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: Up to 3 hours predose
Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)
Time Frame: Day 4: 0.5-1.5 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: 0.5-1.5 hours postdose
Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)
Time Frame: Day 4: 1.5-4 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: 1.5-4 hours postdose
Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)
Time Frame: Day 4: 6-8 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: 6-8 hours postdose
Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)
Time Frame: Month 3: Up to 3 hours predose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: Up to 3 hours predose
Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)
Time Frame: Month 3: 0.5-1.5 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: 0.5-1.5 hours postdose
Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)
Time Frame: Month 3: 2.5-4 hours postdose
Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: 2.5-4 hours postdose
Percentage of Participants With Bleeding Events
Time Frame: Up to 12 months
Bleeding events were categorized into major, clinically relevant non-major bleeding (CRNM), and trivial bleeding events. Major bleeding: overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more; or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults; or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death. CRNM bleeding: overt bleeding not meeting the criteria for major bleeding but associated with: Medical intervention, or Unscheduled contact with a physician, cessation of study treatment, or Discomfort for the subject such as pain, or Impairment of activities of daily life. Trivial bleeding: any other overt bleeding event that does not meet criteria for CRNM bleeding.
Up to 12 months
Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)
Time Frame: Day 1: 0.5-1.5 hours postdose
Absolute prothrombin time was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 1: 0.5-1.5 hours postdose
Absolute PT at Day 1 (1.5-4 Hours Postdose)
Time Frame: Day 1: 1.5-4 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 1: 1.5-4 hours postdose
Absolute PT at Day 4 (Up to 3 Hours Predose)
Time Frame: Day 4: Up to 3 hours predose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.
Day 4: Up to 3 hours predose
Absolute PT at Day 4 (0.5-1.5 Hours Postdose)
Time Frame: Day 4: 0.5-1.5 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: 0.5-1.5 hours postdose
Absolute PT at Day 4 (1.5-4 Hours Postdose)
Time Frame: Day 4: 1.5-4 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: 1.5-4 hours postdose
Absolute PT at Day 4 (6-8 Hours Postdose)
Time Frame: Day 4: 6-8 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: 6-8 hours postdose
Absolute PT at Month 3 (Up to 3 Hours Predose)
Time Frame: Month 3: Up to 3 hours predose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: Up to 3 hours predose
Absolute PT at Month 3 (0.5-1.5 Hours Postdose)
Time Frame: Month 3: 0.5-1.5 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: 0.5-1.5 hours postdose
Absolute PT at Month 3 (2.5-4 Hours Postdose)
Time Frame: Month 3: 2.5-4 hours postdose
Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: 2.5-4 hours postdose
Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)
Time Frame: Day 1: 0.5-1.5 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 1: 0.5-1.5 hours postdose
aPTT at Day 1 (1.5-4 Hours Postdose)
Time Frame: Day 1: 1.5-4 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and average of the participants included in the given time-range is presented here.
Day 1: 1.5-4 hours postdose
aPTT at Day 4 (Up to 3 Hours Predose)
Time Frame: Day 4: Up to 3 hours predose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: Up to 3 hours predose
aPTT at Day 4 (0.5-1.5 Hours Postdose)
Time Frame: Day 4: 0.5-1.5 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here.
Day 4: 0.5-1.5 hours postdose
aPTT at Day 4 (1.5-4 Hours Postdose)
Time Frame: Day 4: 1.5-4 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average for the participants included in the given time-range is presented here.
Day 4: 1.5-4 hours postdose
aPTT at Day 4 (6-8 Hours Postdose)
Time Frame: Day 4: 6-8 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: 6-8 hours postdose
aPTT at Month 3 (Up to 3 Hours Predose)
Time Frame: Month 3: Up to 3 hours predose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: Up to 3 hours predose
aPTT at Month 3 (0.5-1.5 Hours Postdose)
Time Frame: Month 3: 0.5-1.5 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: 0.5-1.5 hours postdose
aPTT at Month 3 (2.5-4 Hours Postdose)
Time Frame: Month 3: 2.5-4 hours postdose
aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: 2.5-4 hours postdose
Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)
Time Frame: Day 1: 0.5-1.5 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 1: 0.5-1.5 hours postdose
Anti-FXa at Day 1 (1.5-4 Hours Postdose)
Time Frame: Day 1: 1.5-4 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 1: 1.5-4 hours postdose
Anti-FXa at Day 4 (6-8 Hours Postdose)
Time Frame: Day 4: 6-8 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Day 4: 6-8 hours postdose
Anti-FXa at Month 3 (Up to 3 Hours Predose)
Time Frame: Month 3: Up to 3 hours predose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: Up to 3 hours predose
Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)
Time Frame: Month 3: 0.5-1.5 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: 0.5-1.5 hours postdose
Anti-FXa at Month 3 (2.5-4 Hours Postdose)
Time Frame: Month 3: 2.5-4 hours postdose
Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here.
Month 3: 2.5-4 hours postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 12 months
TEAEs were defined as those adverse events (AEs) that occurred from the first day of study drug to the last day of study drug + 2 days inclusive. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108075
  • 39039039CHD3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2015-002610-76 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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