Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.

June 27, 2022 updated by: Calliditas Therapeutics AB

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy & Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase

The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).

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

Primary biliary cholangitis (PBC) is a disease of the liver. It is caused a sustained attack by the body's immune system on the bile ducts (canals) inside the liver. This continuous assault leads to their gradual destruction and eventual disappearance. This results in obstruction to the flow of bile which gets worse with disease progression. Once the bile duct injury has been established, the disease progresses due to ongoing obstruction of bile flow, inflammation and scarring of the liver tissue(fibrosis). The liver eventually fails.

This research is looking into whether the study drug is better than a dummy drug when given to patients with PBC. This trial will monitor the patients taking part with regular blood tests and ultrasound liver scans before, during, and at the end of the trial. These measures will allow for the ongoing assessment of liver function, and liver stiffness. It is hoped that in patients in whom the study drug is beneficial, the liver function or stiffness may progress at a slower pace, or may even improve during or at the end of the trial. Liver injury, inflammation and fibrosis Participants will be randomly assigned to 1 of 3 treatment groups (active drug once daily, active drug twice daily or placebo). This is a double blinded study so neither the participants nor the staff responsible for their care will know which group they have been assigned to. During the treatment period, participants will take 4 capsules orally at home in the morning and 4 capsules in the evening for 24 weeks.

Participants will be in the trial for 32 weeks in total (about 8 months) and will attend approximately 8 clinic visits.

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.
111

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

  • Belgium
      • Brussels, Belgium, 1070
        • CUB Hôpital Erasme
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4z6
        • University of Calgary Liver Unit
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E3P4
        • University of Manitoba
    • Quebec
      • Montreal,, Quebec, Canada, H2X0A9
        • Centre hospitalier de l'Universite de Montreal (CHUM) Centre de Recherche Service d'Hepatologie
      • Montréal, Quebec, Canada, H4A3J1
        • McGill University Health Centre (MUHC)
  • Germany
      • Heidelberg, Germany, D-69210
        • Universitätsklinikum Heidelberg
      • Mainz, Germany, D-55131
        • Universitätsmedizin Mainz
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Friedrich-Alexander University Erlangen-Nürnberg
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Johann Wolfgang Goethe-University
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53105
        • Universitätsklinikum Bonn
  • Greece
      • Athens, Greece, 11527
        • Laiko General Hospital
      • Athens, Greece, 11527
        • General Hospital of Athens "Hippocratio"
      • Larissa, Greece, 41100
        • University Hospital of Larissa
  • Israel
      • Haifa, Israel, 3109601
        • RAMBAM Health centre
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization
      • Petach-Tiqva, Israel, 49100
        • Rabin Medical Centre
      • Ramat Gan, Israel, 52621
        • Sheba Medical Centre
      • Tel Aviv, Israel, 3906
        • Sourasky Tel-Aviv Medical Center
  • Italy
      • Ancona, Italy, 60126
        • Università Politecnica delle Marche - Facoltà di Medicina e Chirurgia
      • Bologna, Italy, 40138
        • Policlinico of Bologna
      • Foggia, Italy, 71013
        • San Giovanni Rotondo Hospital (Puglia)
      • Padova, Italy, 35128
        • University Hospital Padova
    • Lombardia
      • Monza, Lombardia, Italy, 20900
        • University of Milan-Bicocca
  • Spain
      • Barcelona, Spain, 8036
        • Hospital Clinic De Barcelona
      • Madrid, Spain, 28222
        • hospital Puerta de Hierro-Majadahonda
      • Madrid, Spain, 28223
        • University of Alcala
      • Malaga, Spain, 29015
        • Virgen de la Victoria University Hospital
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
  • United Kingdom
      • Birmingham, United Kingdom, B152GW
        • University Hospitals Birmingham NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • Swansea, United Kingdom, SA28PP
        • Singleton Hospital
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Plymouth Hospital NHS Trust
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU3 2JZ
        • Hull and East Yorkshire Hospitals NHS Trust
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL13NN
        • Gloucestershire Royal Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust
    • Tayside
      • Dundee, Tayside, United Kingdom, DD19SY
        • Tayside Medical Science Centre (TASC)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • California
      • Sacramento, California, United States, 95817
        • University California Davis
      • Ventura, California, United States, 93003
        • Ventura Clinical Trials
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8019
        • Yale School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Liver and GI Specialist c/o (STAR) LLC
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10029
        • Mount Sinai Health System
      • New York, New York, United States, 10016
        • NYU Hepatology Associates
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Centre
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Dayton Gastroenterology Inc.
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Center for Liver Diseases
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • St Lukes Episcopal Hospital
      • Live Oak, Texas, United States, 78233
        • Pinnacle Clinical Research, PLLC
    • Virginia
      • Newport News, Virginia, United States, 23602
        • Bon Secours Liver Institute of Hampton Roads
      • Richmond, Virginia, United States, 23226
        • Bon Secours Liver Institute of Richmond

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female aged 18 to 80 years, inclusive.
  2. Willing and able to give written informed consent and to comply with the requirements of the study.

  3. PBC diagnosis as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:

    • History of elevated ALP levels (> ULN) for at least 6 months
    • Positive anti-mitochondrial antibody (AMA) titer or if AMA negative or in low titer (< 1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])
    • Liver biopsy consistent with PBC (based on historic liver biopsy), including non-suppurative, destructive cholangitis affecting mainly the interlobular and septal bile ducts.
  4. Serum ALP ≥ 1.5 x ULN.
  5. Serum GGT ≥ 1.5 x ULN.
  6. UDCA treatment for at least 6 months and stable dose for at least 3 months prior to Visit 1.
  7. Subjects being treated for pruritus with colestyramine must be on a stable dose of colestyramine for at least 8 weeks prior to baseline/Day 1 (Visit 2). Subjects must be willing and able to take colestyramine at least 2 hours before or after study medication.
  8. Female subjects of childbearing potential must use a highly effective method of contraception to prevent pregnancy for 4 weeks before randomization and must agree to continue strict contraception for 90 days after last administration of investigational medicinal product (IMP). Male participants with female partners of childbearing potential must be willing to use a condom and require their partner to use an additional form of adequate contraception as approved by the Investigator. This requirement begins at the time of informed consent and ends 90 days after the last administration of IMP. Male study participants must also not donate sperm from baseline until 90 days after the last administration of IMP.

Exclusion Criteria:

  1. A positive pregnancy test or breast-feeding for female subjects.
  2. Any hepatic decompensation, defined as a past or current history of hepatic encephalopathy, gastrointestinal tract bleeding due to esophageal varices, or ascites.
  3. International normalized ratio (INR) > 1.2 unless subject is on anticoagulant therapy.
  4. ALT > 3 x ULN.
  5. Total bilirubin > 1 x ULN.
  6. Planned or current plasmapheresis or other extra-corporeal treatments (e.g., molecular adsorbent recirculation system (MARS)) for treatment-refractory pruritus.
  7. History of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥ 15.
  8. Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma.
  9. Hepatorenal syndrome (type I or II) or Screening serum creatinine > ULN.
  10. Competing etiology for liver disease (e.g., hepatitis C, active hepatitis B, non-alcoholic steatohepatitis (NASH), alcoholic liver disease (ALD), autoimmune hepatitis, primary sclerosing cholangitis, Gilbert's Syndrome).
  11. Subjects receiving prohibited medications within 3 months of Screening (Visit 1) according to the list (a, b and c) provided in Section 6.6.2.
  12. Treatment with any investigational agent within 4 weeks of Visit 1 or 5 half-lives of the investigational medicinal product (whichever is longer).
  13. A history of long QT syndrome.

  14. Evidence of any of the following cardiac conduction abnormalities during the screening period:

    • A QTc Fredericia interval >450 milliseconds for males and >470 milliseconds for females.
    • A second or third degree atrioventricular block not successfully treated with a pacemaker.
  15. History of cancer in the preceding 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, in situ prostate cancer, in situ breast ductal carcinoma, or superficial bladder cancer stage 0).
  16. The occurrence of any acute infection requiring systemic antibiotic therapy within the 2 weeks prior the Screening Visit (Visit 1), or human immunodeficiency virus (HIV) infection.
  17. A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin < 10.0 g/dL (or 6.2 mmol/L).
  18. Any condition which, in the opinion of the Investigator, constitutes a risk or contraindication for the participation of the subject in the study, or which could interfere with the study objectives, conduct, or evaluation.

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: Triple

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: GKT137831 400mg twice daily

GKT137831 400mg twice daily

Patients will self-administer 4 capsules in the morning and 4 capsules in the evening.
Drug: GKT137831
GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.
Other Names:
  • setanaxib
Experimental: GKT137831 400mg once daily

GKT137831 400mg once daily

Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. The capsules in the evening will be placebos.
Drug: GKT137831
GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.
Other Names:
  • setanaxib
Drug: Placebo oral capsule
Matching capsules.
Other Names:
  • Placebo
Placebo Comparator: Placebo Arm
Patients will self-administer 4 capsules in the morning and 4 capsules in the evening. All capsules will be placebos.
Drug: Placebo oral capsule
Matching capsules.
Other Names:
  • Placebo

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
The Percent Change in Serum GGT.
Time Frame: Baseline to week 24 (visit 7)
Percent change in serum GGT from baseline to Week 24 (serum GGT was measured in U/L)
Baseline to week 24 (visit 7)

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
Absolute Change in Serum GGT
Time Frame: From baseline to Weeks 2, 6, 12, 18 and 24
Absolute change in serum GGT from baseline to each assessment.
From baseline to Weeks 2, 6, 12, 18 and 24
Percent Change in Serum GGT
Time Frame: From baseline to Weeks 2, 6, 12, 18 and 24
Percent change in serum GGT from baseline to each assessment (serum GGT was measured in U/L)
From baseline to Weeks 2, 6, 12, 18 and 24
Percent Change in Serum ALP
Time Frame: From baseline to Weeks 2, 6, 12, 18 and 24
Percent change in serum ALP from baseline to each assessment (serum ALP was measured in U/L).
From baseline to Weeks 2, 6, 12, 18 and 24
Absolute Change in Serum ALP
Time Frame: From baseline to Weeks 2, 6, 12, 18 and 24
Absolute change in serum ALP from baseline to each assessment.
From baseline to Weeks 2, 6, 12, 18 and 24
Absolute Change in Serum Conjugated Bilirubin.
Time Frame: From baseline to Weeks 2, 6, 12, 18 and 24
Absolute change in serum conjugated bilirubin from baseline to each assessment.
From baseline to Weeks 2, 6, 12, 18 and 24
Percent Change in Serum Conjugated Bilirubin.
Time Frame: From baseline to Weeks 2, 6, 12, 18 and 24
Percent change in serum Conjugated bilirubin, from baseline to each assessment (serum conjugated bilirubin is measured in μmol/L).
From baseline to Weeks 2, 6, 12, 18 and 24
Absolute Change in Serum Total Bilirubin.
Time Frame: from baseline to Weeks 2, 6, 12, 18 and 24
Absolute change in serum total bilirubin, from baseline to each assessment.
from baseline to Weeks 2, 6, 12, 18 and 24
Percent Change in Serum Total Bilirubin.
Time Frame: from baseline to Weeks 2, 6, 12, 18 and 24
Percent change in Serum Total Bilirubin from baseline to each assessment (serum total bilirubin is measured in μmol/L).
from baseline to Weeks 2, 6, 12, 18 and 24
Absolute Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology).
Time Frame: From baseline to Week 24, in patients with values at baseline and Week 24.
Absolute change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24.
From baseline to Week 24, in patients with values at baseline and Week 24.
Percent Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology).
Time Frame: From baseline to Week 24, in patients with values at baseline and Week 24.
Percent change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24 (liver stiffness is measured in kPa).
From baseline to Week 24, in patients with values at baseline and Week 24.
Percent Change in Serum Levels of Collagen Fragments Indicative of Collagen Formation and Degradation.
Time Frame: From baseline to Weeks 12 and 24.
Percent change in serum levels of collagen fragments indicative of collagen formation and degradation, from baseline to Weeks 12 and 24 (serum levels of collagen fragments are measured in ng/mL).
From baseline to Weeks 12 and 24.
Absolute Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology).
Time Frame: From baseline to Week 24, in patients with values at baseline and Week 24.
Absolute change in liver stiffness by subgroup (>=9.6 kPa) as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24.
From baseline to Week 24, in patients with values at baseline and Week 24.
Percent Change in Liver Stiffness as Assessed by Transient Elastography by Subgroup (FibroScan® or Similar Technology).
Time Frame: From baseline to Week 24, in patients with values at baseline and Week 24.
Percent change in liver stiffness by subgroup (>=9.6 kPa) as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24 (liver stiffness is measured in kPa).
From baseline to Week 24, in patients with values at baseline and Week 24.
Absolute Change in Pruritis Visual Analogue Scale (VAS) Scores
Time Frame: From baseline to Weeks 12 and 24
Absolute Change in Pruritis Visual Analogue Scale (VAS) scores from baseline to weeks 12 and 24- Score from 0 to 10, 0= no itch and 10= severe itch, continuous, day and night intolerable itch.
From baseline to Weeks 12 and 24
Percent Change in Pruritis Visual Analogue Scale (VAS) Scores
Time Frame: From baseline to Weeks 12 and 24
Percent Change in Pruritis Visual Analogue Scale (VAS) scores from baseline to weeks 12 and 24- Score from 0 to 10, 0= no itch and 10= severe itch, continuous, day and night intolerable itch.
From baseline to Weeks 12 and 24
Absolute Change in PBC-40 (Primary Biliary Cholongitis) Domain Scores
Time Frame: From baseline to Weeks 12 and 24
Absolute Change in PBC-40 Domain scores from baseline to weeks 12 and 24 Symptoms domain: items 1 to 7 of the PBC-40 questionnaire (score from 6 to 35). Itch domain: items 8 to 10 of the PBC-40 questionnaire (score from 0 to 15). Fatigue domain: items 11 to 21 of the PBC-40 questionnaire (score from 11 to 55). Cognitive domain: items 22 to 27 of the PBC-40 questionnaire (score from 6 to 30). Emotional domain: items 28, 30 and 33 of the PBC-40 questionnaire (score from 3 to 15). Social domain: items 29, 31, 32, 34 to 40 of the PBC-40 questionnaire (score from 8 to 50). Higher scores mean worse outcome.
From baseline to Weeks 12 and 24
Percent Change in PBC-40 (Primary Biliary Cholongitis) Domain Scores
Time Frame: From baseline to Weeks 12 and 24
Percent Change in PBC-40 Domain scores from baseline to weeks 12 and 24 Symptoms domain: items 1 to 7 of the PBC-40 questionnaire (score from 6 to 35). Itch domain: items 8 to 10 of the PBC-40 questionnaire (score from 0 to 15). Fatigue domain: items 11 to 21 of the PBC-40 questionnaire (score from 11 to 55). Cognitive domain: items 22 to 27 of the PBC-40 questionnaire (score from 6 to 30). Emotional domain: items 28, 30 and 33 of the PBC-40 questionnaire (score from 3 to 15). Social domain: items 29, 31, 32, 34 to 40 of the PBC-40 questionnaire (score from 8 to 50). Higher scores mean worse outcome.
From baseline to Weeks 12 and 24

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.
Calliditas Therapeutics AB

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: Philippe Wiesel, MD, Calliditas Therapeutics AB

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 26, 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.
April 11, 2019

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.
April 11, 2019

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).
June 30, 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.
July 7, 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.
July 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.
June 29, 2022

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 27, 2022

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, 2022

More Information

Terms related to this study

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.
  • GSN000300
  • 2016-004599-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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