A Clinical Trial for CTD-ILD Treatment

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The first objective of this protocol is to assess the tolerability and safety of N-acetylcysteine (NAC) in patients with connective tissue disease related interstitial lung disease (CTD-ILD).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion:

1. Subject gives voluntary written informed consent to participate in the study.

2. Subject has been diagnosed with a connective tissue disease and associated interstitial lung disease confirmed by computed tomography of the lungs along with symptoms of cough and/or shortness of breath.

3. Males and females age greater than 18 years at time of screening.

4. Females of childbearing potential must be willing to use a reliable form of medically acceptable contraception and have a negative pregnancy test confirmed at baseline before starting NAC as per standard of care. Women who are surgically sterile or have been post-menopausal for at least two years are not considered to be of child-bearing potential.

Exclusion:

1. History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.

2. Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.

3. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.