Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

June 12, 2020 updated by: GlaxoSmithKline

Study of Maternal-foetal Cytomegalovirus (CMV) Transmission

This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection. When a pregnant woman is infected with CMV, her immune system (which protects her from infection) is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine, vaginal secretions). The aim of this study is to find out if there is a link between either the pregnant woman's immune response or the presence of the virus in these bodily fluids and the child/foetus being infected with the virus.

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.

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.
160

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.
  • Not Applicable

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

  • Belgium
      • Brussels, Belgium, 1000
        • GSK Investigational Site
      • Bruxelles, Belgium, 1070
        • GSK Investigational Site
      • Bruxelles, Belgium, 1050
        • GSK Investigational Site
      • Charleroi, Belgium, 6000
        • GSK Investigational Site
      • La Louvière, Belgium, 7100
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
      • Mons, Belgium, 7000
        • GSK Investigational Site
      • Wilrijk, Belgium, 2610
        • GSK Investigational Site

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol .
  • A pregnant female, 18 years of age or older at the time of study enrolment.
  • Women with confirmed primary CMV infection.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product.
  • Previous vaccination against CMV infection.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination
  • Major congenital defects, serious chronic illness or organ transplantation.
  • Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy.
  • Documented Human immunodeficiency virus (HIV)-positive subject.
  • Gestational age of more than 34 weeks, as determined by foetal ultrasound.

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group 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: CMV Mothers' Group
Pregnant subjects with confirmed primary CMV infection.
Procedure: Blood sample
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Cord blood sample
Cord blood sample taken at the time of delivery.
Procedure: Saliva swab
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Urine sampling
Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Vaginal swab
Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
Experimental: CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
Procedure: Blood sample
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Cord blood sample
Cord blood sample taken at the time of delivery.
Procedure: Saliva swab
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Urine sampling
Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Procedure: Vaginal swab
Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.

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 Subjects With Any Cytomegalovirus (CMV) Congenital Infection
Time Frame: At Month 0
The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
At Month 0
Number of Subjects With CMV Presence in the Urine
Time Frame: Within 10 days post-delivery (Days 0-9)
Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).
Within 10 days post-delivery (Days 0-9)
Number of Subjects With CMV Presence in the Amniotic Fluid
Time Frame: Within 10 days post-delivery (Days 0-9)
Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).
Within 10 days post-delivery (Days 0-9)
Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus
Time Frame: Within 10 days post-delivery (Days 0-9)
Within 10 days post-delivery (Days 0-9)
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Time Frame: At Month 0
The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine, blood and vaginal secretions every month from study entry to, and including, pregnancy conclusion.
At Month 0
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine and blood every month from study entry to, and including, pregnancy conclusion.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
Time Frame: At Month 0
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
At Month 0
Descriptive Statistics of the Anti-CMV IgM Status
Time Frame: At Month 2
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
At Month 2
Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
Time Frame: At Month 4
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
At Month 4
Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics
Time Frame: At Month 6
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects.
At Month 6
Descriptive Statistics for the Anti-CMV IgM Status
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations
Time Frame: At Month 0
Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.
At Month 0
Anti-gB IgG Antibody Concentrations
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was greater than or equal to (≥) 54 EU/mL.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index
Time Frame: At Month 0
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
At Month 0
Descriptive Statistics of the Anti-gB IgG Avidity Index
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
Time Frame: At Month 0
Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among: cluster of differentiation 40 ligand (CD40L), interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among Human Cytomegalovirus [HCMV] immediate-early gene [IE1] antigen, HCMV glicoprotein B [gB] antigen, HCMV lysate antigen and HCMV pp65 antigen).
At Month 0
CMV-specific CD4 T-cell Frequencies
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
Time Frame: At Month 0
Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
At Month 0
CMV-specific CD8 T-cell Frequencies
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
Time Frame: At Month 0
Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
At Month 0
CMV-specific Proliferating CD4 T Cells Frequencies
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)

Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).

Note: Results were retrieved by subtracting the background without imputing the negative and zero values, this generated negative values.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies
Time Frame: At Day 0 = study entry
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
At Day 0 = study entry
Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations
Time Frame: At Month 2
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
At Month 2
Concentrations of Anti-CMV Tegument Protein IgG Antibodies
Time Frame: At Month 4
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
At Month 4
Anti-CMV Tegument Protein IgG Antibody Concentrations
Time Frame: At Month 6
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
At Month 6
Concentrations of Anti-CMV IgG Antibodies
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Time Frame: At Day 0 = study entry
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
At Day 0 = study entry
Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Time Frame: At Month 2
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
At Month 2
Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status
Time Frame: At Month 4
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
At Month 4
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status
Time Frame: At Month 6
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
At Month 6
Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time Frame: At Month 0
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
At Month 0
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time Frame: At Month 2
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
At Month 2
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time Frame: At Month 4
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
At Month 4
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time Frame: At Month 6
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
At Month 6
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time Frame: At Month 0
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
At Month 0
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time Frame: At Month 2
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
At Month 2
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time Frame: At Month 4
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
At Month 4
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time Frame: At Month 6
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
At Month 6
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Time Frame: At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)

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.
GlaxoSmithKline

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

Study record dates

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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.
December 9, 2010

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.
November 6, 2013

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.
June 17, 2015

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).
November 30, 2010

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.
December 1, 2010

First Posted (Estimate)

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.
December 2, 2010

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.
June 29, 2020

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.
June 12, 2020

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, 2020

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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.
  • 113134

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