GKT137831 in IPF Patients with Idiopathic Pulmonary Fibrosis
NCT ID: NCT03865927
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2020-09-07
2024-11-30
Brief Summary
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This clinical trial represents the bedside application of a series of NOX translational and basic studies and discoveries, over several years, from the laboratory of Dr. Victor Thannickal.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
• Arm A (n=30) - GKT137831 Treatment:
GKT137831 will be administered orally, at a dose of 400 mg bid, for a total of 24 weeks.
• Arm B (n=30) - Placebo Treatment:
Arm B subjects will receive matching placebo for the same duration.
Participants will be followed in face-to-face visits with trial personnel every 6 weeks for 24 weeks to assess drug effects and monitor safety during their treatments, and by phone surveillances one month thereafter.
TREATMENT
TRIPLE
Study Groups
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GKT137831
GKT137831 will be administered orally, at a dose of 400 mg twice daily, for a total of 24 weeks.
GKT137831
GKT137831 is a NOX enzyme inhibitor
Placebo Oral Tablet
Identically-appearing placebo oral tablets will be administered orally, twice daily, for a total of 24 weeks.
Placebo Oral Tablet
see Arm/Group description
Interventions
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Placebo Oral Tablet
see Arm/Group description
GKT137831
GKT137831 is a NOX enzyme inhibitor
Eligibility Criteria
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Inclusion Criteria
2. A diagnosis of IPF that fulfills current American Thoracic Society (ATS) Consensus Criteria.
3. IPF duration \<5 years, based on the date of definitive diagnosis.
4. Ability and willingness to give informed consent and adhere to study requirements.
5. Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>70% of predicted values
Exclusion Criteria
2. History of malignancy, excluding basal or squamous cell skin cancer and low-risk prostate cancer, the latter defined as stage T1 or T2a, with prostate specific antigen \<10 ng/dl. NOX inhibition is not known to promote cancer, and these criteria are within current guidelines.
3. The occurrence of any acute infection requiring systemic antibiotic therapy within 2 weeks prior to Screening (Visit 1).
4. Treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, calcineurin inhibitors, etc.), given increased risks of opportunistic infections.
5. Treatment with any investigational agent within 4 weeks of Screening (Visit 1) or 5 half-lives of the investigational medicinal product (whichever is longer).
6. Fertile women who do not agree to contraception or abstinence, or who are breast feeding. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.
7. Subjects with known hypersensitivity to GKT137831 or its excipients (e.g. capsule "bulking" agents).
8. A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin \< 10.0 g/dL (or 6.2 mmol/L).
9. Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, congestive heart failure (NYHA Class III or IV), or stroke, including a transient ischemic attack.
10. Evidence of cardiac conducting abnormalities, defined as second or third degree atrial-ventricular (AV) block not successfully treated with a pacemaker, or a personal or family history of long QT syndrome (QTc interval \>450 msec for males or 470 msec for females).
11. End-stage renal disease requiring dialysis.
12. Undergoing transplantation evaluation, or listed with the United Network for Organ Sharing (UNOS) as a lung transplantation candidate at the time of enrollment in this trial.
13. Liver function tests (transaminases, alkaline phosphatase, direct and total bilirubin) \>3x upper limit of normal values
40 Years
85 Years
ALL
No
Sponsors
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Temple University
OTHER
Tulane University
OTHER
University of Michigan
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Steven R. Duncan, MD
PI
Principal Investigators
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Steven R Duncan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Temple University Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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IRB-300001635
Identifier Type: -
Identifier Source: org_study_id