A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis

未提供0 个研究点目标入组 532 人开始时间: 待定

适应症

试验速览

暂无简介。

•Age >=14 years
•Body weight >=30.0 kg
•Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
•Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
•Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
•Chest radiograph consistent with active TB disease
•Able to provide sputum sample
•Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
•Willing to have HIV test (unless previous positive result confirmed)
•For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for >=3 months, Viral load <200 copies/mL, and CD4 count >100 cells/uL

•Known/suspected resistance to BDQ, PMD, LZD, or QBS
•Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for >=1 month within past 3 months
•Severe extrapulmonary TB
•Abnormal laboratory values: ALT/AST >2.5xULN, Total bilirubin >1.5xULN,
•eGFR <60 mL/min/1.73m2, Hemoglobin <8 g/dL, Platelets <100,000 cells/mm3,
•WBC <2.0x10^9/L, ANC <1000 cells/uL, and HbA1c >9.0%
•Pre-existing peripheral neuropathy (>=Grade 1), optic neuritis, or visual impairment
•Co-enrollment in other therapeutic trials
•QTcF >450 msec (males) or >470 msec (females)
•Clinically significant cardiovascular disorders
•Bleeding disorders
•Conditions interfering with X-ray or sputum assessment
•Drug allergies/hypersensitivity to study medications
•Pregnancy or breastfeeding
•Positive drug screen (case-by-case assessment for some substances)
•Serious mental disorders
•Karnofsky score <60
•BMI <16.0 kg/m2
•Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
•Pulmonary conditions other than TB (silicosis, fibrosis)
•Active SARS-CoV-2 infection
•Use of prohibited medications
•Blood/plasma donation within 30 days
•Current use of herbal remedies or traditional medicines

发起方

未提供