Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

September 20, 2019 updated by: Genfit

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

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.
45

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 2

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

  • France
      • Paris, France, 75012
        • Hôpital Saint-Antoine
  • Germany
      • Frankfurt, Germany, 60590
        • University Hospital Frankfurt
      • Koln, Germany, 50937
        • Clinic for gastroenterology and hepatology
      • Mainz, Germany, 55131
        • Johannes Gutenberg University
  • Spain
      • Barcelona, Spain, 08036
        • Liver Unit, University of Barcelona
      • Barcelona, Spain, 08041
        • Hospital De La Sant Creu St. Pau
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TT
        • University of Birmingham Centre for Liver Research
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Liverpool, United Kingdom, L7 8XP
        • The Royal Liverpool University Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hosptials NHS Foundation Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona
    • Florida
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Diseases
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Health Institution
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must have provided written informed consent

  2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:

    • History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)
    • Positive Anti-Mitochondrial Antibodies (AMA) titers (> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
    • Liver biopsy consistent with PBC
  3. ALP >= 1.67x upper limit of normal (ULN)
  4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit
  5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment.

Exclusion Criteria:

  1. History or presence of other concomitant liver diseases
  2. Screening creatine phosphokinase (CPK) > upper limits of normal (ULN)
  3. Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) > 5 ULN
  4. Screening total bilirubin > 2 ULN
  5. Screening serum creatinine > 1.5 mg/dl
  6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate [eGFR] of less than 60 mL/min/1.73 m^2).
  7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)
  8. Platelet count <150 X 10^3/microliter
  9. Albumin <3.5 g/dL
  10. Presence of clinical complications of PBC or clinically significant hepatic decompensation
  11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
  12. Known history of human immunodeficiency virus (HIV) infection
  13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Placebo Comparator: Placebo
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Drug: Placebo
Two coated tablets daily for 12 weeks
Active Comparator: Elafibranor 80 mg
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Drug: Elafibranor 80 mg
Two coated tablets daily for 12 weeks
Other Names:
  • GFT505
Active Comparator: Elafibranor 120 mg
Study subjects will take two tablets per day orally before breakfast with a glass of water each morning
Drug: Elafibranor 120 mg
Two coated tablets daily for 12 weeks
Other Names:
  • GFT505

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
Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint)
Time Frame: Baseline, Week 12 (Endpoint)
Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.
Baseline, Week 12 (Endpoint)

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 Response Defined by Composite Risk Scores (ALP< 1.67 * Upper Limit of Normal [ULN] at Endpoint, Total Bilirubin [BIL] Within Normal Limits at Endpoint, and Greater Than [>] 15% ALP Reduction From Baseline to Endpoint)
Time Frame: Up to Week 12 (Endpoint)
Percentage of participants with response defined by Composite Risk Scores (ALP Less than [<] 1.67 * ULN at endpoint, Total BIL within normal limits at endpoint, and > 15% ALP reduction from baseline to Endpoint) was reported.
Up to Week 12 (Endpoint)
Percentage of Participants With Response Defined by Composite Risk Scores (ALP < 2 * Upper Limit of Normal at Endpoint, Total Bilirubin Within Normal Limits at Endpoint, and > 40% ALP Reduction From Baseline to Endpoint)
Time Frame: Up to Week 12 (Endpoint)
Percentage of participants with response defined by composite risk scores (ALP < 2 * ULN at endpoint, Total BIL within normal limits at endpoint, and > 40% ALP reduction from baseline to endpoint) was reported.
Up to Week 12 (Endpoint)
Percentage of Participants With Response Based on PARIS I Risk Score at Endpoint
Time Frame: At Week 12 (Endpoint)
Percentage of participants with response based on Paris I risk score was defined as ALP less than or equal to (<=) 3 * ULN and aspartate aminotransferase (AST) <= 2 * ULN and bilirubin within normal limits.
At Week 12 (Endpoint)
Percentage of Participants With Response Based on PARIS II Risk Score at Endpoint
Time Frame: At Week 12 (Endpoint)
Percentage of participants with response based on Paris II risk score was defined as ALP <= 1.5 * ULN and AST <= 1.5 * ULN and bilirubin within normal limits.
At Week 12 (Endpoint)
Percentage of Participants With Response Based on Toronto I Risk Score at Endpoint
Time Frame: At Week 12 (Endpoint)
Percentage of participants with response based on Toronto I risk score was defined as ALP <= 1.67 *ULN.
At Week 12 (Endpoint)
Percentage of Participants With Response Based on Toronto II Risk Score at Endpoint
Time Frame: At Week 12 (Endpoint)
Percentage of participants with response based on Toronto II risk scores was defined as ALP <= 1.75 * ULN.
At Week 12 (Endpoint)
Median Percentage Risk as Assessed by United Kingdom-Primary Biliary Cholangitis (UK-PBC) Risk Total Score at Endpoint
Time Frame: At Week 12 (Endpoint)
UK-PBC risk score at endpoint estimated that the median percentage risk that a participant treated with ursodeoxycholic acid (UDCA) will develop liver failure requiring liver transplant in 5, 10 and 15 years. UK-PBC score was calculated at each of the 3 survivor functions 1-baseline survival function^exp(0.0287854*[alpEPxuln-1.722136304] - 0.0422873*[{(altastEPxuln/10)^-1} - 8.675729006] + 1.4199 * [ln{bilEPxuln /10}+2.709607778] -1.960303*[albxlln -1.17673001]-0.4161954*[ pltxlln -1.873564875]). Where: Baseline survivor function=0. 982 (at 5 years); 0. 941 (at 10 years); 0.893 (at 15 years). alpEPxuln = ALP at endpoint/upper level normal ALP; altastEPxuln=(ALT, AST) at endpoint/upper level normal of the value; bilEPxuln=bilirubin at endpoint/upper level normal bilirubin; albxlln=albumin at baseline/albumin lower level normal; pltxlln=platelet count at baseline/ platelet count lower level normal.
At Week 12 (Endpoint)
Percentage of Participants With Response Defined by 10, 20 and 40 Percent Reduction in Alkaline Phosphatase
Time Frame: At Week 12 (Endpoint)
Percentage of participants with response (defined by at least 10%, 20%, and 40% decrease in ALP from baseline to Endpoint) reported.
At Week 12 (Endpoint)
Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Endpoint
Time Frame: At Week 12 (Endpoint)
The response was defined by normalized ALP levels (ALP ULN 105 units per liter [U/L] for females, 129 U/L for males) at endpoint.
At Week 12 (Endpoint)
Percentage of Participants With Response Defined by Normalized Bilirubin (BIL) at Endpoint
Time Frame: At Week 12 (Endpoint)
The response was defined by normalized BIL levels (BIL ULN <1.20 milligram per deciliter [mg/dL]) at endpoint.
At Week 12 (Endpoint)
Percentage of Participants With Response Defined by Normalized Albumin (ALB) Levels at Endpoint
Time Frame: At Week 12 (Endpoint)
The response was defined by normalized ALB levels (3.5-5.2 gram per deciliter [g/dL] for ages 18-60 years; 3.2-4.6 g/dL for ages 61-91 years) at endpoint.
At Week 12 (Endpoint)
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in ALT levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Aspartate Aminotransferase (AST) Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in AST levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Gamma-glutamyl Transferase (GGT) Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in GGT levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in 5 Prime (') Nucleotidase Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in 5' nucleotidase levels at endpoint was reported. 5' nucleotidase is an enzyme used as a biomarker of hepatobiliary cholestasis and is less sensitive but more specific than GGT and ALP.
Baseline, Week 12 (Endpoint)
Change From Baseline in Total Bilirubin (BIL) Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in total BIL levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Conjugated Bilirubin Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in conjugated bilirubin levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Albumin Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in albumin levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Cholesterol Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in cholesterol levels at endpoints was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in LDL-cholesterol at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in HDL-cholesterol levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Triglycerides Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in triglycerides levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Total Free Bile Acid Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in total free bile acid levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Total Conjugated Bile Acid Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in total conjugated bile acid levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Total Bile Acid Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in total bile acid levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in 7 Alpha-hydroxy-4-cholesten-3-one Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in 7 alpha-hydroxy-4-cholesten-3-one levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Fibroblast Growth Factor-19 Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in fibroblast growth factor-19 levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Immunoglobulin M (IgM) Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in IgM levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Tumor Necrosis Factor Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in tumor necrosis factor levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Transforming Growth Factor Beta Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in transforming growth factor beta levels at endpoint was reported,
Baseline, Week 12 (Endpoint)
Change From Baseline in Interleukin 6 Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in interleukin 6 levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Plasminogen Activator Inhibitor-1 Antigen (AG) Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in plasminogen activator inhibitor-1 AG levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Cytokeratin-18 Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in cytokeratin-18 (M30 and M65) levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Autotaxin Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in autotaxin levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
C-reactive Protein Level at Endpoint
Time Frame: Week 12 (Endpoint)
C-reactive protein level at endpoint was reported.
Week 12 (Endpoint)
Change From Baseline in Haptoglobin Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in haptoglobin levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in Fibrinogen Levels at Endpoint
Time Frame: Baseline, Week 12 (Endpoint)
Change from baseline in fibrinogen levels at endpoint was reported.
Baseline, Week 12 (Endpoint)
Change From Baseline in 5D-Itch Scale Total Score
Time Frame: Baseline, Week 12 (Endpoint)
5 dimensional (5D)-Itch Scale is a reliable, multidimensional measure of itching that has been validated in participants with chronic pruritus to detect changes over time. It consists of 5 domains: duration, degree, direction, disability, and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items (sleep, leisure/social, housework/errands, work/school). All items of the first four domains were measured on a 5-point Likert scale. The distribution domain included 16 potential locations of itch, including 15 body part items (head/scalp, soles, face, palms, chest, abdomen, back, buttocks, thighs, lower legs, tops of feet/toes, tops of hands/fingers, upper arms, groin, forearms) and one point of contact with clothing or bandages. Scores of each of five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus).
Baseline, Week 12 (Endpoint)
Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score
Time Frame: Baseline, Week 12 (Endpoint)
The VAS is a reliable and validated method of pruritus assessment. The VAS is adequate in assessing the severity of the symptom; it does not take into account other aspects of pruritus, such as the relative impact of pruritus on quality of life. The VAS, for pruritus assessment, requires the participant to use abstract thought processes to convert their itch severity to a mark on a continuum. A participant draws a line anywhere on the scale ranging from 0 to 10 (where 0 represents 'no itching' and 10 represents 'worst possible itching') that best represents the severity of participant's itching and the scoring involves manual measuring of the mark with a ruler on range of 0 to 100 millimeter (mm). Higher scores indicate worse itching.
Baseline, Week 12 (Endpoint)
Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores
Time Frame: Baseline, Week 12 (Endpoint)
PBC-40 QoL Questionnaire is a patient-derived, disease-specific QoL measure developed and validated for use in PBC. It consists of 9 domains with total 40 questions as: 1) digestion and diet (questions 1-3, total score range: 3-15); 2) experiences (questions 4-7, total score range: 4-20); 3) itching (questions 8-10, total score range: 3-15); 4) fatigue (questions 11-18, total score range: 8-40); 5) effort and planning (questions 19-21, total score range: 3-15); 6) memory and concentration (questions 22-27, total score range: 6-30); 7) affects you as a person (questions 28-33, total score range: 6-30); 8) affects your social life (questions 34-37, total score range: 4-20); 9) overall impact on your life (questions 38-40, total score range: 3-15). PBC-40 QoL Questionnaire has 40 questions, each scored on scale of 1-5 (1 = least impact, 5 = greatest impact). For each domain, scoring involved summing individual question response scores. Higher scores indicate poorer quality of life.
Baseline, Week 12 (Endpoint)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events
Time Frame: Up to Week 12
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical (investigational) product and which does not necessarily have to have a causal relationship with this treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another medically important condition. TEAEs is defined as (1) it is not present when active phase of study (time of first dose) begins and is not a chronic condition that is part of patient's medical history, or it is present at start of active phase or as part of patient's medical history, but severity/frequency increases during active phase.
Up to Week 12

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.
Genfit

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: Clinical Head, Genfit

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

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.
April 5, 2017

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.
October 31, 2018

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.
October 31, 2018

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 28, 2017

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.
April 20, 2017

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 21, 2017

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.
September 24, 2019

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.
September 20, 2019

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.
September 1, 2019

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.
  • GFT505B-216-1
  • 2016-003817-80 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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