Status:
ACTIVE_NOT_RECRUITING
Phase 2 Trial Assessing TBAJ876 or Bedaquiline, with Pretomanid and Linezolid in Adults with Drug-sensitive Pulmonary Tuberculosis
Lead Sponsor:
Global Alliance for TB Drug Development
Conditions:
Pulmonary TB
Pulmonary Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambu...
Detailed Description
Participants will be treated up to 26 weeks with either: * TBAJ876 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks * TBAJ876 50 mg + pretomanid 200 mg + line...
Eligibility Criteria
Inclusion
- Signed informed consent
- DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB
- Of non-childbearing potential OR using effective birth control methods
- Body weight ≥ 35 kg
Exclusion
- Karnofsky score \< 60 at screening
- Any evidence of extrapulmonary TB
- Cardiovascular or QT prolongation risk factors
- Pregnant or breast-feeding
- Any of the following lab toxicities:
- Platelets \<100,000/mm³
- Creatinine \>1.3 x ULN
- Haemoglobin \<9.5 g/dL or \<95 g/L
- Absolute neutrophil count \<800/mm³
- Serum potassium less than the lower limit of normal for the laboratory.
- ALT and/or AST ≥2.5 x ULN
- Total bilirubin ≥1.6 x ULN
- Direct bilirubin \>1 x ULN
- Haemoglobin A1c ≥8.0%
- Total lipase ≥1.5 x ULN
- Total amylase ≥1.5 x ULN
- CPK \>3 x ULN (if \>3 x ULN, enquire about the participant's recent strenuous activity and consider repeating the test within the screening window)
- TSH \>1 x ULN
- Positive results at screening for HBsAg, HAV IgM, or hepatitis C antibodies
- For participants living with HIV only:
- CD4+ count\<200 cells/μL.
- WHO Clinical Stage 4 HIV disease
- Participant does not agree to use DTG/TFV/3TC during trial if ARV therapy is indicated, and randomised to the TBAJ876 or the B-Pa-L regimen
- If initiation of ARV therapy is indicate, participants who are known to be intolerant, non-responsive to DTG/TFV/3TC or have DTG/TFV/3TC as a contraindication.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT06058299
Start Date
October 24 2023
End Date
June 1 2026
Last Update
February 17 2025
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
National Center for Tuberculosis and Lung Diseases
Tbilisi, Georgia, 0101
2
Care Clinical Trial Group Inc.
Dasmariñas, Philippines, 4114
3
Tropical Disease Foundation
Makati City, Philippines, 1230
4
Lung Center of the Philippines
Quezon City, Philippines, 1104