Trial Outcomes & Findings for A Clinical Trial for CTD-ILD Treatment (NCT NCT01424033)

Results Overview

Not recorded. Study terminated due to departure of PI.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

5 participants

Primary outcome timeframe

Every 3 months

Results posted on

2017-04-06

5 subjects consented but did not participate in study due to departure of PI from institution.

5 subjects consented to participate due to the PI departed the institution. Numbers in patient flow were updated to reflect this.

Participant milestones
Measure	N-Acetylcysteine This is an open label trial, all patient will be entered into one treatment arm. N-Acetylcysteine: 600mg by mouth, three times daily for 12 months
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Withdrawal data not reported

A Clinical Trial for CTD-ILD Treatment

Baseline characteristics by cohort
Measure	N-Acetylcysteine n=5 Participants This is an open label trial, all patient will be entered into one treatment arm. N-Acetylcysteine: 600mg by mouth, three times daily for 12 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

Timeframe: Every 3 months

Not recorded. Study terminated due to departure of PI.

Outcome measures
Measure	N-Acetylcysteine This is an open label trial, all patient will be entered into one treatment arm. N-Acetylcysteine: 600mg by mouth, three times daily for 12 months
Pulmonary Function Tests	0

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	N-Acetylcysteine n=5 participants at risk This is an open label trial, all patient will be entered into one treatment arm. N-Acetylcysteine: 600mg by mouth, three times daily for 12 months
Reproductive system and breast disorders Cancer recurrence	20.0% 1/5 • Number of events 1
Cardiac disorders Death	20.0% 1/5 • Number of events 1
Cardiac disorders Hospitalization, tachycardia	20.0% 1/5 • Number of events 1

Adverse event data not reported

University of Michigan

Phone: 7349365566