Status:
COMPLETED
GKT137831 in IPF Patients with Idiopathic Pulmonary Fibrosis
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Temple University
Tulane University
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
A placebo-controlled, multicenter, randomized trial to test GKT137831 in ambulatory patients with idiopathic pulmonary fibrosis. This drug is an inhibitor of nicotinamide adenine dinucleotide phosphat...
Eligibility Criteria
Inclusion
- Age between 40-85 years old.
- A diagnosis of IPF that fulfills current American Thoracic Society (ATS) Consensus Criteria.
- IPF duration \<5 years, based on the date of definitive diagnosis.
- Ability and willingness to give informed consent and adhere to study requirements.
- Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) \>70% of predicted values
Exclusion
- Diagnosis of major comorbidities expected to interfere with study participation
- 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.
- The occurrence of any acute infection requiring systemic antibiotic therapy within 2 weeks prior to Screening (Visit 1).
- 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.
- Treatment with any investigational agent within 4 weeks of Screening (Visit 1) or 5 half-lives of the investigational medicinal product (whichever is longer).
- 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.
- Subjects with known hypersensitivity to GKT137831 or its excipients (e.g. capsule "bulking" agents).
- A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin \< 10.0 g/dL (or 6.2 mmol/L).
- 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.
- 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).
- End-stage renal disease requiring dialysis.
- 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.
- Liver function tests (transaminases, alkaline phosphatase, direct and total bilirubin) \>3x upper limit of normal values
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03865927
Start Date
September 7 2020
End Date
November 30 2024
Last Update
December 10 2024
Active Locations (4)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
3
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
4
Temple University Medical Center
Philadelphia, Pennsylvania, United States, 19140