LiveSMART Trial to Prevent Falls in Patients With Cirrhosis

July 7, 2026 updated by: Elliot B. Tapper, University of Michigan

LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis

This multicenter trial is being conducted to determine if sequential lactulose and Tele (virtual) Tai-Chi reduces the rate of injurious fall, non-injurious falls, incident overt Hepatic Encephalopathy (HE), and death or liver transplant over 24 weeks.

Participants that are enrolled will be randomized to stage one of this project for approximately 12 weeks. After completing stage one, participants will be re-randomized to stage 2 of the project that will last approximately 12 more weeks.

The study hypothesizes that sequential lactulose/TeleTai-Chi will reduce falls, incident overt HE, death and physical frailty and will improve cognitive function, and Health Related Quality of Life (HRQOL) over 24 weeks compared to other treatment combinations.

As detailed below, an observational component that enrolls caregivers of the trial participants is being conducted. Upon completion, Participants listed in the record here only include trial participants; and the observational component was moved to a new registration for clarity, NCT07140120.

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

The Clinicaltrials.gov registration record was updated as requested by Patient-Centered Outcomes Research Institute (PCORI) based on protocol amendment version 3.0 after approval by the Institutional Review Board. These changes included: the additional aim for a supplemental observational study to assess social determinants of health, financial burdens, etc., and includes recruitment of the caregivers for this supplemental study along with the trial participants, as well as updated outcomes for the trial. After further discussion with PCORI, these changes were removed from this record and used to create a separate record for the supplemental study focused on caregivers (NCT07140120).

The caregivers that are enrolled are not in the clinical trial. All clinical trial information is provided in this record, but upon completion of enrollment and consideration of transparent results reporting, it was decided to move all the items related to the observational supplemental study to its own record.

To improve clarity in the record, the two arms representing stage 1 of the project were incorporated into the remaining four representing stage 2, so the remaining arms now represent both stage 1 and stage 2.

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.
233

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Research Institute (BSW)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of cirrhosis based on histology and/or imaging specified in the protocol.

  • Evidence of portal hypertension - must meet at least one of the following criteria:

    • Ascites (present or within past 2 years)
    • Varices (seen by Esophagogastroduodenoscopy or by Ultrasound(US) or cross-sectional imaging)
    • Fibroscan Liver stiffness measurement (LSM) >25 kilopascals (kPa) (if no other factors present)
    • Magnetic resonance elastography (MRE) LSM > 5 kPa (if no other factors present)
    • Acoustic radiation force impulse LSM > 17kpa (if no other factors present)
    • Hepatic vein pressure gradient > 10 millimetres of mercury (mmHg)
    • Portal hypertensive gastropathy seen on Esophagogastroduodenoscopy
    • Platelet count < 80/ units per liter (uL)
    • Recanalized umbilical vein (by US or cross-sectional imaging)
  • Access to Wireless Fidelity (Wi-Fi) at home
  • Owns or access to a smartphone, tablet or computer
  • English or Spanish speaking
  • Willing to participate in exercise program

Exclusion Criteria:

  • Overt hepatic encephalopathy (HE) within 6 months, requiring >28 days total of lactulose
  • Took lactulose for non - HE reasons for >28 days total in last 6 months
  • Took Rifaximin for > 28 days total in last 6 months
  • Model for End Stage Liver Disease (MELD) > 25 (Exception: MELD > 25 with clinically stable End-Stage Renal Disease (ESRD) for whom the bilirubin is < 5 g/dL)
  • Barcelona Clinic Liver Cancer (BCLC) > C Hepatocellular Carcinoma (HCC)
  • Currently taking Sorafenib, Atezolizumab/Bevacizumab, Regorafinib, or Cabozatinib
  • Greater than (>) 3 paracentesis/month in last 2 months
  • Active Metastatic solid malignancy or acute leukemia within last 3 years
  • Severe cognitive, vision, or hearing impairment (without use of corrective lenses or hearing assist devices) or psychiatric illness precluding study participation
  • Currently participates in Tai-Chi or performs >150 min/week vigorous physical activity
  • Currently receiving lower body physical and/or occupational therapy
  • Living in an assisted living facility
  • Hemoglobin A1C > 12 (within past 12 months)
  • Requires a low galactose diet
  • Deemed unsuitable by the study investigator

Inclusion Criteria for the Caregivers of the participants:

  • Adult > 18 years of age
  • Informal caregiver of a participant enrolled in LIVE-SMART
  • English speaking

Exclusion Criteria for the Caregivers of the participants:

- Non-English speaking

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential 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.
Active Comparator: Enhanced Usual Care group followed by investigator recommended exercise
Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Investigator-Recommended Exercise at Stage 2
Behavioral: Enhanced Usual Care
Patients will be provided and counseled on two methods which will enhance care. The first is a handout on nutrition recommendations and protein supplementation. This will include the recommendation of both high protein snacks during the daytime (e.g., protein bars) and a high-protein night-time snack (e.g., peanut butter and crackers). The second will be to counsel participants on falls prevention methods that can be enacted in day-to-day life. All participants will be provided with a standard hand-out of Centers for Disease Control and Prevention (CDC)-endorsed fall-risk reduction measures.
Behavioral: Investigator recommended exercise
Participants randomized to enhanced usual care will be reminded of standard fall precautions outlined in the Fall Prevention Primer that were provided in Stage 1 and will receive exercise recommendations.
Experimental: Treatment (Lactulose) plus Enhanced Usual Care then TeleTai-Chi exercise classes
Lactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then TeleTai-Chi exercise classes at Stage 2
Behavioral: Enhanced Usual Care
Patients will be provided and counseled on two methods which will enhance care. The first is a handout on nutrition recommendations and protein supplementation. This will include the recommendation of both high protein snacks during the daytime (e.g., protein bars) and a high-protein night-time snack (e.g., peanut butter and crackers). The second will be to counsel participants on falls prevention methods that can be enacted in day-to-day life. All participants will be provided with a standard hand-out of Centers for Disease Control and Prevention (CDC)-endorsed fall-risk reduction measures.
Drug: Lactulose

Patients will be prescribed lactulose and will also receive enhanced usual care. Lactulose will be taken on a specific schedule based on the average number of bowel movements on average per day. It will be started at 15 milliliter (mL) dose and will be instructed to slowly increase the lactulose dose over the course of the first week of Stage 1 participation. The prescribed maximum dose will be 30 mL (20g) twice daily. The dose will slowly increase toward the maximum or until participants reach 2-3 soft bowel movements daily.

Participants that receive Lactulose during stage 1 will continue this in stage 2.

Behavioral: TeleTai-Chi (virtual)
TeleTai-Chi will be taught remotely via live Zoom classes of up to 15 patients by a certified TeleTai-Chi instructor three times per week (for approximately 12 weeks). Classes will be conducted via a HIPAA-compliant Zoom server through the University of Michigan. Participants will be instructed to use Zoom by smartphone, tablet, or computer. High-Definition Multimedia Interface (HDMI) cables and other device specific equipment to connect devices to televisions will be provided.
Experimental: Enhanced Usual Care group followed by Tele-Tai Chi exercise classes
Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to EUC then Tele-Tai Chi exercise classes at Stage 2
Behavioral: Enhanced Usual Care
Patients will be provided and counseled on two methods which will enhance care. The first is a handout on nutrition recommendations and protein supplementation. This will include the recommendation of both high protein snacks during the daytime (e.g., protein bars) and a high-protein night-time snack (e.g., peanut butter and crackers). The second will be to counsel participants on falls prevention methods that can be enacted in day-to-day life. All participants will be provided with a standard hand-out of Centers for Disease Control and Prevention (CDC)-endorsed fall-risk reduction measures.
Behavioral: TeleTai-Chi (virtual)
TeleTai-Chi will be taught remotely via live Zoom classes of up to 15 patients by a certified TeleTai-Chi instructor three times per week (for approximately 12 weeks). Classes will be conducted via a HIPAA-compliant Zoom server through the University of Michigan. Participants will be instructed to use Zoom by smartphone, tablet, or computer. High-Definition Multimedia Interface (HDMI) cables and other device specific equipment to connect devices to televisions will be provided.
Experimental: Treatment (Lactulose) plus Enhanced Usual Care then recommended exercise
Lactulose plus Enhanced Usual Care (EUC) at Stage 1 (12 weeks) and then re-randomization to Lactulose plus EUC then Investigator-Recommended Exercise at Stage 2
Behavioral: Enhanced Usual Care
Patients will be provided and counseled on two methods which will enhance care. The first is a handout on nutrition recommendations and protein supplementation. This will include the recommendation of both high protein snacks during the daytime (e.g., protein bars) and a high-protein night-time snack (e.g., peanut butter and crackers). The second will be to counsel participants on falls prevention methods that can be enacted in day-to-day life. All participants will be provided with a standard hand-out of Centers for Disease Control and Prevention (CDC)-endorsed fall-risk reduction measures.
Behavioral: Investigator recommended exercise
Participants randomized to enhanced usual care will be reminded of standard fall precautions outlined in the Fall Prevention Primer that were provided in Stage 1 and will receive exercise recommendations.
Drug: Lactulose

Patients will be prescribed lactulose and will also receive enhanced usual care. Lactulose will be taken on a specific schedule based on the average number of bowel movements on average per day. It will be started at 15 milliliter (mL) dose and will be instructed to slowly increase the lactulose dose over the course of the first week of Stage 1 participation. The prescribed maximum dose will be 30 mL (20g) twice daily. The dose will slowly increase toward the maximum or until participants reach 2-3 soft bowel movements daily.

Participants that receive Lactulose during stage 1 will continue this in stage 2.

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
Number of Participants Experiencing a Hierarchical Composite of Events Over 24 Weeks: Injurious Falls, Non-injurious Falls, Incident Hepatic Encephalopathy, Liver Transplant, and Death/Transplant
Time Frame: Baseline to 24 weeks

Composite outcome is defined as any of the following:

• Injurious Fall: Fracture, dislocation, cut, head injury, soft - tissue injury requiring medical intervention including: Hospitalization or overnight observation in the Emergency Room (ER); surgery, transfusion, stitches

  • Non - Injurious Fall: Inadvertently coming to rest on the floor or lower level

    • Include falls that result in minor injuries that are addressed with first aid (e.g., ice, bandage)
  • Incident Overt HE: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator
  • Death: Mortality with any cause
  • Liver transplant: Replacement of a diseased liver with the healthy liver from another person because of acute-on-chronic liver failure (using the EASL-CLIF-C definition consisting of an acute increase in the bilirubin and/or INR, acute kidney injury, overt HE, hypertension, and hypoxia).
Baseline to 24 weeks

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
Injurious Falls
Time Frame: Baseline to 24 weeks
Results reflect the number of participants who experienced at least one injurious fall. Injurious falls include: Fracture, dislocation, cut, head injury, soft - tissue injury requiring hospitalization.
Baseline to 24 weeks
Non-Injurious Falls
Time Frame: Baseline to 24 weeks
Results reflect the number of participants who experienced at least one non-injurious fall. Non- injurious falls include: Inadvertently coming to rest on the floor or lower level.
Baseline to 24 weeks
Incident Overt Hepatic Encephalopathy (HE)
Time Frame: Baseline to 24 weeks
Incident Overt HE includes: Acute disorientation requiring hospitalization or the initiation of HE - directed therapy, confirmed by a gastroenterologist or study investigator.
Baseline to 24 weeks
Death/Transplant for Acute-on-Chronic Liver Failure (ACLF)
Time Frame: Baseline to 24 weeks
Results reflect participants who died, or who received a liver transplant because of ACLF.
Baseline to 24 weeks
Incident of Liver Transplant for Non-ACLF Reason
Time Frame: Baseline to 24 weeks
Results reflect the number of participants who received replacement of a diseased liver with the healthy liver from another person for any reason other than ACLF.
Baseline to 24 weeks
Days-alive and Out-of-the-hospital
Time Frame: Approximately 26 Weeks
Days-alive and out-of-the-hospital is a continuous value, 1 for each day alive, 0 for days in hospital. Participants were queried and data was also abstracted from the Electronic Medical Record (EMR). Results reflect the average number of days participants were alive and out of the hospital.
Approximately 26 Weeks
Change in Cognitive Function Based on the Animal Naming Test (ANT)
Time Frame: Baseline to 24 weeks
The animal naming test assesses cognitive function. It is a timed test that that consists of participants listing as many unique animals as possible in 60 seconds. This is a validated test used for the assessment of hepatic encephalopathy. The score is the number of unique animals named (higher is better). Results reflect change from baseline.
Baseline to 24 weeks
Change in Visual Analog Scale (VAS)
Time Frame: Baseline to 24 weeks
This was a 1-item global rating of health scored 0-100. A score of 100 means the best health and 0 means the worst health imagined. Results reflect change from baseline.
Baseline to 24 weeks
Change in The Patient Reported Outcome Measurement Information System (PROMIS)-29+2 v2.1 Profile (PROPr)
Time Frame: Baseline to 24 weeks
PROPr is the combined score of the two scales in the PROMIS 29+2, a quality-of-life scale and a pain-rating scale, and is used to calculate a preference score. The scores from both scales provide an overall summary of health-related quality of life based on multiple domains summarizing a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). Results reflect change from baseline.
Baseline to 24 weeks
Change in Depression Based on The Patient Reported Outcome Measurement Information System (PROMIS)-29+2 v2.1
Time Frame: Baseline to 24 weeks
There were 4 questions that participants completed regarding depression. The scores were converted to t scores, which were normalized from the raw scores. The t score ranged from 0-100 with 0 denoting worst depression and 100 indicating no depression. Results reflect the change from baseline.
Baseline to 24 weeks
Change in Sleep Quality Based on the PROMIS-29+2 v2.1
Time Frame: Baseline to 24 weeks
There were 4 questions that participants completed regarding sleep quality. The scores were converted to t scores, which were normalized from the raw scores. The t score ranged from 0-100 with 0 denoting worst sleep quality and 100 indicating best sleep quality. Results reflect change from baseline.
Baseline to 24 weeks
Physical Frailty Based on the Liver Frailty Index
Time Frame: Baseline to 24 weeks
Physical frailty was assessed with this index and was a composite of handgrip, timed chair-stands, and balance. The index ranged from -1.26 (robust) to 6.9 (frail), 50th percentile is 3.9. For individuals enrolled remotely, the study team assessed chair-stands.
Baseline to 24 weeks
Change in Physical Frailty Based on the Activities of Daily Living (ADLs)
Time Frame: Baseline to 24 weeks
Activities of daily living (ADLs), is a validated self-reported measure (disability is defined as >1 ADL deficit) recommended by the American Society for Transplantation and AASLD. The score ranged from 0 to 6 (6 indicating full independence, 4 moderate impairment, and 2 or less severe functional impairment). Results reflect change from baseline.
Baseline to 24 weeks
Intervention Fidelity
Time Frame: 24 weeks
Evaluation of intervention fidelity was assessed at 50% and 100% of study completion. Results reflect participants who maintained fidelity by completing at least one of the following key intervention components: coordinator trainings, lactulose prescriptions ordered, enhanced usual care components delivered, Short Message Service (SMS) assessments sent, study visits completed, or exercise sessions completed.
24 weeks
Participant Adherence
Time Frame: 24 weeks
Adherence to lactulose, Tai-Chi, and nighttime protein supplementation was monitored. Results reflect the number of participants who discontinued their assigned intervention.
24 weeks
Participant Satisfaction With the Trial and Interventions Based on the Patient Global Impression of Change (PGIC)
Time Frame: 12 weeks and 24 weeks
Satisfaction with the trial was assessed using the 6-item Patient Global Impression of Change (PGIC). Participants selected from 1 (very much improved) to 7 (very much worse). Lower scores indicated higher satisfaction.
12 weeks and 24 weeks
Change in Short Form (SF) - 8
Time Frame: 24 weeks
The SF-8 is an abbreviated 8-item version of an original 36-item health survey (SF-36). It is a generic multipurpose quality of life instrument. It contains psychometrically based physical and mental health summary measures. The eight domains include general health, physical functioning, role physical, bodily pain, vitality, social functioning, mental health and role emotional. The scores were converted to t scores, which were normalized from the raw scores. The t score ranged from 0-100 with 0 denoting worst quality of life and 100 indicating best quality of life. Results reflect change from baseline.
24 weeks

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.
University of Michigan

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.
Patient-Centered Outcomes Research Institute

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.
  • Principal Investigator: Elliott Tapper, MD, University of Michigan
  • Principal Investigator: Marina Serper, MD, MS, University of Pennsylvania

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.
June 13, 2023

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.
March 7, 2025

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.
March 7, 2025

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).
March 20, 2023

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.
March 20, 2023

First Posted (Actual)

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.
April 3, 2023

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.
July 31, 2026

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.
July 7, 2026

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.
May 1, 2026

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.
  • HUM00225275
  • CER-2021C3-24907 (Other Identifier: PCORI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be deposited in a repository.

IPD Sharing Time Frame

From January 1, 2027, through perpetuity.

IPD Sharing Access Criteria

Study documentation will be released on the website and deidentified data will be available upon request through the Virtual Data Enclave (VDE).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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