PER-021-23尚未招募2 期
A Phase 2b/c, Multi-Arm, 2-Stage, Duration Randomized Trial of the Efficacyand Safety of Two to Four Months Treatment with Regimens Containing Bedaquiline, OPC-167832, and Sutezolid, Plus Either Pretomanid or Delamanid, in Adults with Pulmonary Tuberculosis.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •For Stage 1, participants are required to meet all of the following inclusion criteria when assessed:
- •1) Able to provide written, informed consent prior to initiation of any trial-related procedures or treatments, and able, in the opinion of the Investigator, to comply with all the requirements of the trial.
- •2) Male or female participants between 18 and 65 years of age (inclusive) at the screening visit.
- •3) Body weight =35.0 kg and body mass index (BMI) =16.0 at the screening visit.
- •4) Newly diagnosed within the past 3 weeks prior to informed consent, untreated (=4 days of treatment), drug-susceptible pulmonary TB, as defined by all of the following:
- •a) Confirmation of Mtb infection: Mtb positivity on a molecular test (eg, Xpert Ultra, Hain LPA) conducted on a sputum specimen for trial screening
- •b) Evidence of non-paucibacillary disease: =1+ sputum smear positivity for acid-fast bacilli using fluorescent microscopy, as defined by the International Union Against Tuberculosis and Lung Disease (IUATLD)/WHO scale, OR a Xpert Ultra semi-quantitative result of ‘medium’ or ‘high’ on the sputum specimen for trial screening
- •c) Drug-susceptible TB: Isoniazid and rifampicin resistance not detected, as determined by a molecular test (eg, Hain LPA, Xpert Ultra, Xpert MTB/XDR) conducted on a sputum
- •specimen for trial screening
- •d) Clinical signs and/or symptoms consistent with active TB in the opinion of the Investigator
- •e) Chest radiograph consistent with active TB in the opinion of the Investigator. Note, the
- •Investigator is permitted, but not required, to incorporate a radiologist’s interpretation into
- •their assessment of a participant’s chest radiograph
- •5) Able to spontaneously produce sputum.
- •6) Female participants of childbearing potential (FOCBP) must agree to use 2 approved methods of contraception with their male sexual partners or abstain from heterosexual intercourse throughout their participation in the trial (see Section 13.3).
- •7) Male participants must agree to use an approved method of contraception with their female sexual partners of childbearing potential or abstain from heterosexual intercourse throughout their participation in the trial (see Section 13.3).
- •For Stage 2, inclusion criteria #4 will be changed to the following:
- •4) Newly diagnosed within the past 3 weeks of informed consent, untreated (=4 days of
- •treatment), drug-susceptible or rifampicin-/multi-drug resistant pulmonary TB, as defined by all of the following:
- •a) Confirmation of Mtb infection: Mtb positivity on a molecular test (eg, Xpert Ultra, Hain LPA) conducted on a screening sputum specimen
- •b) Evidence of non-paucibacillary disease: =1+ sputum smear positivity for acid-fast bacilli using fluorescent microscopy, as defined on the IUATLD/WHO scale, OR Xpert Ultra semi-quantitative result of ‘medium’ or ‘high’ on the sputum specimen for trial screening
- •c) Resistance pattern:
- •i. For DS TB arm, isoniazid and rifampicin resistance not detected on a molecular test (eg, Hain LPA, Xpert Ultra, Xpert MTB/XDR) conducted on a screening sputum specimen,
- •ii. For RR/MDR TB arm, either rifampicin resistance (RR TB) OR rifampicin and isoniazid resistance (MDR TB) detected on a molecular test (eg, Hain LPA, Xpert Ultra,
- •Xpert MTB/XDR) conducted on a screening sputum specimen
- •Participants with RR or MDR TB must also have fluoroqui
排除标准
- •Participants are excluded from the trial if any of the following criteria apply.
- •1) Suspected or documented extra-thoracic TB. Confirmed or suspected lymph node TB is not considered exclusionary. The presence of a pleural effusion considered not clinically significant together with pulmonary TB is not exclusionary.
- •2) Known, or suspected of having, resistance to a rifamycin, isoniazid, ethambutol, pyrazinamide, delamanid, pretomanid, bedaquiline, linezolid, tedizolid, or sutezolid either confirmed by the laboratory, or based on epidemiological history, such as a known source case with said resistance.
- •3) Received any prior treatment for active Mtb disease (>4 days) within the past 1 year of informed consent.
- •4) Received any treatment with a fluoroquinolone active against Mtb (ie, levofloxacin,
- •moxifloxacin, ciprofloxacin) or an aminoglycoside for more than 14 days within the 3 months prior to informed consent even if the medication was given for a different indication than TB treatment.
- •5) Any known prior exposure to delamanid, pretomanid, bedaquiline, OPC-167832, or any oxazolidinone (linezolid, tedizolid, delpazolid, or sutezolid).
- •6) Evidence of an active clinically significant/uncontrolled metabolic, gastrointestinal,
- •neurological (including peripheral neuropathy), psychiatric, endocrine (including uncontrolled diabetes), hematologic, ophthalmologic (particularly optic neuritis), or liver disease; active malignancy; or other medical co-morbidity considered significant enough by the Investigator that the participant should not enter the trial.
- •7) Significant history of, or current clinically relevant cardiovascular disorder, such as heart failure, coronary artery disease, uncontrolled hypertension, arrhythmia, tachyarrhythmia, prolonged QT syndrome, or presence of symptom(s) strongly suggestive of such a problem, such as exertional chest pressure/pain or unexplained syncope.
- •8) Significant history of, or current evidence of an active clinically significant/poorly controlled pulmonary disease, such as asthma, COPD, silicosis, or lung fibrosis (other than TB), considered as severe by the Investigator. In particular, any underlying pulmonary condition that could significantly interfere with the assessment of X-ray images, interpretation of sputum findings, or otherwise compromise the participant’s participation in the trial is exclusionary based on the Investigator’s judgement. Clinically significant post-COVID-19 pulmonary sequelae should be considered exclusionary.
- •9) If HIV-infected, having any of the following present:
- •a) Not on antiretroviral treatment at time of screening or taking antiretroviral treatment for <3 months prior to screening, OR
- •b) CD4+ T-cell count <200 cells/µL during the screening period, OR
- •c) HIV viral load >200 copies/mL during the screening period, OR
- •d) Evidence of a currently active opportunistic malignancy or infection related to HIV other than TB that requires treatment with a prohibited concomitant medication (oral candidiasis is not exclusionary).
- •10) If female, currently pregnant or breastfeeding, OR having a positive serum or urine pregnancy test during the screening period, OR planning to become pregnant within the 12-month period after the screening period. Refer to Section 13.3 (Appendix 3, Section 13.3) for more information.
- •11) Current significant drug and/or a
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