Status:
TERMINATED
A Clinical Trial for CTD-ILD Treatment
Lead Sponsor:
University of Michigan
Conditions:
Interstitial Lung Disease
Connective Tissue Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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).
Detailed Description
The investigators will assess tolerability and safety at scheduled intervals via standard of care physical exam findings, monitoring complete blood count, serum chemistry, and pulmonary function tests...
Eligibility Criteria
Inclusion
- Inclusion:
- Subject gives voluntary written informed consent to participate in the study.
- 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.
- Males and females age greater than 18 years at time of screening.
- 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:
- History of severe chronic kidney disease defined as a glomerular filtration rate of less than 30.
- Hemoglobin concentration less than 70% of the lower limit of the normal range at time of screening.
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01424033
Start Date
December 1 2011
Last Update
April 6 2017
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109