Clinical trial NCT05079126: Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease
Official title: Double-Blind, Placebo-Controlled Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Interstitial Lung Disease
Lead sponsor: Diffusion Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2021-10-15
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.


Eligibility criteria: Inclusion Criteria:

1. Male or Female, age 30 to 85 years at screening
2. Able to provide informed consent and agree to adhere to all study visits and requirements
3. Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug
4. Established diagnosis of ILD (clinical, radiographic, or histologic)
5. SpO2 ≥ 88% at rest by pulse oximetry while breathing ambient air
6. Free of any active cardiovascular or neuromuscular disease, at PI discretion
7. Clinically stable disease with no major medication changes in the last 4 weeks
8. Forced vital capacity (FVC) ≥ 45% of predicted (within past 6 months)
9. DLCO corrected for hemoglobin 30-90% of predicted, inclusive (within past 6 months)
10. Sars-CoV-2 negative at screening

Exclusion Criteria:

1. Known allergy to study medication
2. Pregnancy or lactation
3. Current smoker
4. Inability to perform pulmonary function testing
5. Active infection at screening or day of study visit
6. Known pulmonary hypertension (PH) requiring PH-specific treatment
7. AST/ALT ≥ 3x ULN and/or total bilirubin ≥ 2x ULN
8. Received any investigational medicine (IMP) within past 30 days
9. Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant.
10. Current alcohol or substance abuse
11. Known active or latent hepatitis B or C
12. History of end-stage liver or renal disease
13. Positive COVID test anytime within 3 months of screening. Note:

    Patients who were previously vaccinated for COVID are allowed
14. History of venous thromboembolic disease
15. History of acute or chronic ophthalmologic conditions currently requiring treatment

Primary outcomes:
measure: Change from baseline at 30 minutes in DLCO after administration of a single dose of TSC versus placebo in patients with ILD
timeFrame: 30 minutes
Secondary outcomes:
measure: Change from baseline in 6MWT after administration of a single dose of TSC versus placebo in patients with ILD
timeFrame: 60 minutes
measure: Change from baseline in HRR after each 6MWT
timeFrame: 60 minutes
measure: Change from baseline in the Borg Scale after the 6MWT
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates, P.A.
state: Arizona
Study officials:
References: