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PA-824 for Tuberculosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Saint Louis University - Center for Vaccine Development, Saint Louis, MOTuberculosisPA-824 - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
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Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Group 1 -Mild Hepatic Impairment
1
PF-07081532
1
Participants with mild hepatic impairment

Study Objectives

7 Primary · 8 Secondary · Reporting Duration: Day -1, 2, 5, and 12

Day 12
Summary of ECG data
Day 12
Summary of physical examination findings (height at baseline, and weight at serial time points)
Summary of vital signs at serial time points
Day -1, 2, 5, and 12
Summary of safety laboratory parameters
Day 12
Incidence of related adverse events
Incidence of serious adverse events
Severity of related adverse events
Severity of serious adverse events
Day 5
AUC(0-infinity): Area under the concentration time-curve extrapolated to infinity at specified pre-dose and post-dose time points
AUC(0-last): Area under the concentration time-curve to the last concentration above the lower limit of quantitation at specified pre-dose and post-dose time points
CL/F: Apparent oral clearance calculated from Dose/AUC(0-infinifty) at specified pre-dose and post-dose time points
Cmax: Maximum Pretomanid concentration at specified pre-dose and post-dose time points
Tmax: Time of maximum Pretomanid concentration at specified pre-dose and post-dose time points
Vd/F: Apparent Volume of Distribution at specified pre-dose and post-dose time points
t(1/2): Apparent terminal elimination half-life at specified pre-dose and post-dose time points

Trial Safety

Safety Progress

1 of 3

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1
Group 1 -Mild Hepatic Impairment
1
PF-07081532
1
Participants with mild hepatic impairment

Side Effects for

DS-TB: 2 Months HRZE/ 4 Months HR
32%Hyperuricaemia
25%Aspartate aminotransferase increased
22%Arthralgia
18%Gamma-glutamyltransferase increased
16%Alanine aminotransferase increased
16%Pruritus generalised
12%Visual acuity reduced
12%Blood uric acid increased
9%Rash
7%Rhinitis
7%Pruritus
7%Anaemia
7%Myalgia
7%Haematuria
7%Headache
6%Vomiting
6%Blood glucose increased
6%Dizziness
6%Neuropathy peripheral
6%Proteinuria
4%Diarrhoea
4%Blood alkaline phosphatase increased
4%Abdominal pain
4%Pain in extremity
4%Haemoptysis
4%Nausea
3%Protein urine present
3%Musculoskeletal pain
3%Gastroenteritis
3%Somnolence
3%Decreased appetite
3%Rash pruritic
3%Rash papular
3%Pleuritic pain
1%Upper respiratory tract infection
1%Fungal skin infection
1%Seizure
1%Acquired hydrocele
1%Flank pain
1%Furuncle
1%Lymphadenopathy
1%Pulmonary Tuberculosis
1%Intentional overdose
1%Toothache
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT02342886) in the DS-TB: 2 Months HRZE/ 4 Months HR ARM group. Side effects include: Hyperuricaemia with 32%, Aspartate aminotransferase increased with 25%, Arthralgia with 22%, Gamma-glutamyltransferase increased with 18%, Alanine aminotransferase increased with 16%.

Trial Design

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

Experimental Treatment

36 Total Participants · 4 Treatment Groups

Primary Treatment: PA-824 · No Placebo Group · Phase 1

Child-Pugh A (Mild hepatic impairment)
Drug
Experimental Group · 1 Intervention: PA-824 · Intervention Types: Drug
Child-Pugh B (Moderate hepatic impairment)
Drug
Experimental Group · 1 Intervention: PA-824 · Intervention Types: Drug
Child-Pugh C (Severe hepatic impairment)
Drug
Experimental Group · 1 Intervention: PA-824 · Intervention Types: Drug
Non-hepatically impaired controls
Drug
Experimental Group · 1 Intervention: PA-824 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pretomanid
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day -1, 2, 5, and 12

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,165 Previous Clinical Trials
4,936,999 Total Patients Enrolled
128 Trials studying Tuberculosis
449,941 Patients Enrolled for Tuberculosis

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you are a man and can have children, you agree to use birth control to avoid getting someone pregnant for three months after receiving treatment.
Your doctor needs to perform certain medical tests like a biopsy, nuclear scan, CT, MRI, or ultrasound to determine if you can participate in the study.
If you are a woman, you either cannot have children or agree to use birth control during the study.
You cannot have children because you have gone through menopause for at least 2 years, had surgery to remove both ovaries or had a hysterectomy.
You are able to give your written permission before any study procedures can be done.
You must be between 18 and 70 years old, including both ages.
Your recent medical tests must show normal results within the past 21 days before joining the study, and also must be taken again within 72 hours after you start the study.
Your blood tests and urine tests are normal according to the doctor.
You have liver damage or cirrhosis, which has been classified as mild, moderate, or severe based on specific criteria.
If you are a woman who could become pregnant, you must use two types of birth control to participate in the study. These can include methods like a condom, birth control pills, or an intrauterine device (IUD).
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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