This trial is testing the effects of a new drug, Pretomanid, on people with different levels of liver damage. There will be approximately 36 people in the study, and it will last for 24 months. The primary objective is to see how Pretomanid affects people with different levels of liver damage, and the secondary objective is to see if Pretomanid is safe for people with different levels of liver damage.
7 Primary · 8 Secondary · Reporting Duration: Day -1, 2, 5, and 12
Side Effects for
4 Treatment Groups
Child-Pugh A (Mild hepatic impairment)
1 of 4
Child-Pugh B (Moderate hepatic impairment)
1 of 4
Child-Pugh C (Severe hepatic impairment)
1 of 4
Non-hepatically impaired controls
1 of 4
36 Total Participants · 4 Treatment Groups
Primary Treatment: PA-824 · No Placebo Group · Phase 1
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Age 18 - 70 · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
What is the enrollment size of this clinical trial?
"Affirmative. Records on clinicaltrials.gov proclaim that this experiment is still looking for participants, with the first posting made on December 11th 2017 and most recent edits occurring in December 1st 2022. 36 patients must be recruited from 2 different medical centres." - Anonymous Online Contributor
How is PA-824 typically employed in medical practice?
"PA-824 offers a therapeutic approach to tuberculosis, treatment-intolerant pulmonary tb, and other forms of the infections." - Anonymous Online Contributor
Is enrollment for this trial open at the moment?
"This clinical trial, which was initially advertised on the 11th of December 2017, is still actively recruiting. The details were last updated on 1st December 2022 according to clinicaltrials.gov." - Anonymous Online Contributor
What can be discerned about the safety of PA-824 from current research?
"Taking into consideration the limited data available, our team has concluded that PA-824 ranks low on the safety scale with a score of 1." - Anonymous Online Contributor
Have any other clinical trials utilized PA-824 as a therapeutic agent?
"In 2017, the first research into PA-824 was conducted at Duke University School of Medicine's Clinical Research Institute. 18 studies have been successfully completed since then and there are 4 live clinical trials with a majority taking place in Saint Louis, Missouri." - Anonymous Online Contributor
Are there any restrictions regarding participation in this clinical experiment?
"This trial requires 36 participants, aged between 18 and 70, suffering from tuberculosis. In addition to this age requirement, the following criteria must be met: minimal levels of certain chemistry values; no severe hepatic impairment or cirrhosis; non-childbearing potential (post-menopausal for two years minimum); female patients using acceptable forms of contraception during study duration; male subjects refraining from fathering a child for 3 months after dosing with an appropriate birth control measure. Furthermore, all candidates must provide voluntary written consent prior to any procedures being carried out." - Anonymous Online Contributor
Is this study recruiting participants who are aged 75 or older?
"This trial is enrolling patients who are of age 18 or older, yet younger than 70." - Anonymous Online Contributor