[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Chest Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,71,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100613597","phase-3-innovating-shorter-all--oral-precised-treatment-regimen-for-rifampicin-resistant-tuberculosisblmz-chinese-cohort-100613597",false,"NCT07268664","Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort","INSPIRE-BLMZ","Inclusion Criteria:\n\n* The participant (and their guardian if the participant lacks civil capacity) voluntarily signs the informed consent form (ICF) prior to enrollment.\n* The participant (and their guardian) indicates willingness to complete all steps and intervention periods of the study.\n* Male or female, aged ≥12 years, with a body weight ≥30 kilograms (kg).\n* Bacteriologically confirmed pulmonary tuberculosis, with molecular or phenotypic drug susceptibility testing (DST) results within the last 3 months confirming Rifampicin resistance and susceptibility to at least one of Moxifloxacin (MFX) or Levofloxacin (LFX).\n* Sputum or respiratory lavage fluid collected during the screening period is culture-positive for Mycobacterium tuberculosis, with DST results indicating Rifampicin resistance and susceptibility to at least one of MFX or LFX.\n* Females of childbearing potential are not pregnant (as confirmed by a negative pregnancy test), voluntarily agree to pregnancy testing, and are willing to use highly effective contraception from the time of ICF signing until 3 months after the end of study treatment.\n* For males of reproductive potential, use condoms or other methods to ensure effective contraception for their partner.\n* Females who are breastfeeding are willing to discontinue breastfeeding from the time of ICF signing until 3 months after the end of study treatment.\n* Voluntary acceptance of HIV testing; if the result is positive, voluntary acceptance of antiretroviral therapy.\n\nExclusion Criteria:\n\n* Previous treatment with any of the drugs Bedaquiline (BDQ) or Linezolid (LZD) for more than 30 days.\n* Concurrent hematogenous disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator.\n* Current use of medications prohibited by the study protocol, and the investigator judges that the priority of continuing said medication for patient benefit outweighs participation in this study.\n\n（Note: If the investigator judges that the benefit of participating in this study is higher and obtains the participant's consent, the prohibited medication should be discontinued with an adequate washout period before participation.）\n\n* Known history of hypersensitivity to any drug in the protocol.\n* Current participation in any other investigational drug clinical trial.\n* Presence of cardiovascular disease risk at screening:\n\n  1. QTcF interval \\>450 milliseconds (ms). (Note: If QTcF \\>450 ms is detected, one unscheduled visit during the screening period is allowed for re-assessment.)\n  2. History of clinically significant arrhythmia within 60 days prior to enrollment, which in the investigator's opinion may increase risk upon study participation.\n  3. Decompensated heart failure.\n  4. Grade 3 hypertension not at control target.\n  5. Abnormal thyroid function.\n  6. Abnormal serum calcium, magnesium, or potassium levels. (Note: Isolated electrolyte disturbances without underlying disease may be considered for re-screening after corrective treatment.)\n  7. Other conditions deemed by the investigator to pose a cardiovascular disease risk.\n* History of optic neuropathy or peripheral neuropathy, which in the investigator's opinion may progress\u002Fworsen during the study or is unsuitable for study participation.\n* Evidence of liver disease at screening:\n\n  1. Active viral hepatitis: Positive HBsAg, or positive HBeAg and HBV DNA, or positive HCV RNA test, accompanied by persistent or recurrent abnormal ALT.\n  2. Decompensated cirrhosis.\n* History of renal disease or renal disease-related manifestations at screening:\n\n  1. History of unstable or rapidly progressive renal disease.\n  2. Moderate\u002Fsevere renal impairment or end-stage renal disease (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²).\n  3. Serum creatinine (Cr) ≥133 μmol\u002FL (1.5 mg\u002FdL) for males, or Cr ≥124 μmol\u002FL (1.4 mg\u002FdL) for females.\n* Other laboratory abnormalities at screening:\n\n  1. Hemoglobin level \\\u003C 8.0 g\u002FdL.\n  2. Platelet count \\\u003C75,000 \u002Fmm³.\n  3. Absolute neutrophil count (ANC) \\\u003C1000 \u002Fmm³.\n  4. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\>3 times the upper limit of normal (ULN).\n  5. Total bilirubin \\>2 times ULN, or \\>1.5 times ULN accompanied by other abnormal liver enzymes.\n  6. Albumin \\\u003C30 g\u002FL.\n* Pregnant or breastfeeding.\n* Any other condition (e.g., severe psychiatric disorder, neurological condition, substance abuse) that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to adhere to the protocol.","ALL","12 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The goal of this clinical trial is to learn if the all-oral, shorter-course BLMZ regimen can treat Rifampicin-Resistant Tuberculosis (RR-TB) in Chinese participants aged 12 years and older. The main questions it aims to answer are:\n\nWhat is the proportion of participants with a favorable outcome at 18 months after starting the BLMZ regimen? What is the safety profile of the BLMZ regimen, as measured by the incidence of Grade 3 or higher adverse events and serious adverse events during the treatment period? This is a single-arm study, so there is no comparison group. Researchers will compare the study results to historical data to see if the BLMZ regimen shows sufficient efficacy and safety in the Chinese population.\n\nParticipants will:\n\nUndergo screening tests to confirm eligibility, including tests for TB bacteria and drug resistance.\n\nReceive the BLMZ regimen (Bedaquiline, Linezolid, Moxifloxacin\u002FLevofloxacin, and Pyrazinamide) orally for 9 months.\n\nAttend regular clinic visits for safety assessments, medication refills, and tests (e.g., sputum tests, blood tests, ECG, CT scans) during the 9-month treatment period and then every 3 months during a 15-month post-treatment follow-up period until 24 months after starting the treatment.",[26,27,28,29],"Rifampicin Resistant Tuberculosis","Pulmonary Tuberculosis","Tuberculosis","Drug-resistant Tuberculosis",[31,32,33,34],"drug-resistant tuberculosis","all-oral regimen","9 month regimen","tuberculosis","NOT_YET_RECRUITING","2025-11-26",{"date":38,"type":39},"2025-12-08","ACTUAL",{"date":41,"type":20},"2025-12-01",{"date":43,"type":20},"2028-08-31",{"name":45,"class":46},"Beijing Chest Hospital","OTHER",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100574829","phase-2-phase-ii-study-of-adebrelimab-chemotherapy-and-apatinib-for-advanced-pulmonary-neuroendocrine-tumors-100574829","NCT06764368","Phase II Study of Adebrelimab, Chemotherapy, and Apatinib for Advanced Pulmonary Neuroendocrine Tumors","A Phase II, Single-arm, Multicenter Clinical Study of Adebrelimab Combined With Chemotherapy and Apatinib as First-line Treatment for Unresectable Locally Advanced or Metastatic Pulmonary Neuroendocrine Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years, no gender restriction;\n2. Pathologically confirmed unresectable locally advanced or metastatic pulmonary neuroendocrine tumors (including large cell neuroendocrine carcinoma, small cell lung cancer, and carcinoid tumors). For carcinoid tumors, patients must be atypical carcinoid cases deemed by the investigator to require systemic treatment due to tumor-related symptoms or continuous tumor growth.\n3. No prior systemic anti-tumor treatment;\n4. Expected survival of at least 3 months;\n5. ECOG performance status: 0-2;\n6. At least one evaluable lesion based on imaging, according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), with at least one measurable tumor lesion (non-lymph node lesion with a maximum diameter ≥ 10 mm or lymph node lesion with a short diameter ≥ 15 mm at baseline);\n7. Patients with brain metastases must either be asymptomatic or have stable brain metastases to be eligible;\n8. Normal function of major organs;\n9. Women of childbearing potential must have used reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result. Both male and female patients of childbearing potential must agree to use adequate contraception during the study and for 6 months after treatment;\n10. Subjects must voluntarily participate in the study, sign informed consent, demonstrate good compliance, and agree to follow-up.\n\nExclusion Criteria:\n\n1. Subjects with extensive leptomeningeal metastases or active brain metastases with significant symptoms;\n2. Spinal cord compression not definitively treated with surgery and\u002For radiotherapy, or previously diagnosed and treated spinal cord compression without clinical evidence of stabilization for at least 1 week prior to randomization;\n3. Uncontrolled or symptomatic hypercalcemia;\n4. Prior treatment with any T-cell co-stimulation or immune checkpoint inhibitors;\n5. Use of immunosuppressive drugs within 14 days prior to the first dose of Adebrelimab;\n6. Active tuberculosis (TB) within 48 weeks before screening or a history of active TB infection, regardless of prior treatment;\n7. Vaccination with live attenuated or preventive vaccines within 4 weeks before the first dose or planned vaccination during the study;\n8. History of allogeneic bone marrow transplantation or solid organ transplantation;\n9. Severe cardiovascular disease;\n10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n11. Any active autoimmune disease or a history of autoimmune disease;\n12. Coagulation abnormalities (INR \\> 1.5 or prothrombin time \\[PT\\] \\> ULN + 4 seconds or APTT \\> 1.5 ULN), bleeding tendency, or current thrombolytic or anticoagulation therapy;\n13. Major surgery, traumatic injury, fracture, or ulcer within 4 weeks prior to enrollment, or planned major surgery during the study;\n14. Severe infections such as sepsis or septic shock within 14 days before enrollment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia;\n15. Significant hemoptysis within 2 months prior to enrollment, defined as more than half a teaspoon (2.5 ml) of blood daily, or any significant clinical bleeding or bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, baseline fecal occult blood ++ or higher, or vasculitis;\n16. HBsAg positive with levels exceeding the upper limit of normal (1000 copies\u002Fml or 500 IU\u002Fml); patients with past or cured HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of HBsAg, with normal HBV DNA during screening) may be included; HCV antibody positive with HCV viral load exceeding the upper limit of normal\u002FHCV RNA or HCV Ab indicating acute or chronic infection; known HIV positive status or acquired immunodeficiency syndrome (AIDS);\n17. Patients with a known history of allergies or suspected allergies to the study drug or any components of the study;\n18. Participation in another interventional clinical trial or use of any investigational product within 4 weeks prior to signing the informed consent form (ICF);\n19. History of substance abuse or inability to quit, or mental disorders;\n20. History of or concurrent malignancies requiring active treatment within the past 5 years;\n21. Other conditions judged by the investigator to be unsuitable for inclusion;\n22. Patients with asymptomatic, stable, typical\u002Fatypical carcinoid tumors are not eligible for this study.","18 Years",{"count":57,"type":20},39,[59],"PHASE2","This is an investigator-initiated research project aimed at exploring the efficacy and safety of Adebrelimab combined with chemotherapy and Apatinib as first-line treatment for unresectable locally advanced or metastatic pulmonary neuroendocrine tumors.\n\nThis is an experimental study that has been reviewed and approved by the Ethics Committee of Beijing Chest Hospital. The study plans to enroll 39 treatment-naïve patients with unresectable locally advanced or metastatic pulmonary neuroendocrine carcinoma, who will receive first-line treatment with Adebrelimab combined with chemotherapy and Apatinib to evaluate its efficacy and safety.",[62],"Neuroendocrine Tumors","2025-01-02",{"date":65,"type":39},"2025-01-08",{"date":67,"type":20},"2025-01-01",{"date":69,"type":20},"2028-06-01",{"name":45,"class":46},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100552678","phase-4-the-safety-and-efficacy-of-bdlbedaquiline-plus-delamanid-plus-linezolid-regimen-in-subjects-with-pulmonary-infection-of-multi-drug-resistant-tuberculosis-mdr-tb-or-rifampicin-resistant-tuberculosis-rr-tb-100552678","NCT06476210","The Safety and Efficacy of BDL(Bedaquiline Plus Delamanid Plus Linezolid) Regimen in Subjects With Pulmonary Infection of Multi-drug Resistant Tuberculosis (MDR-TB) or Rifampicin-Resistant Tuberculosis (RR-TB)","Inclusion Criteria\n\n* 1.A patient with multi-drug resistant\u002Frifampicin-resistant pulmonary tuberculosis (MDR\u002FRR-TB) with recent laboratory evidence (culture or molecular testing) within the last two months\n* 2.Age 18 years above\n* 3.No prior use of neither bedaquiline, delamanid, linezolid, or use for less than 4 weeks\n* 4.Positive culture result for mycobacterial at baseline(regardless smear positive or negative). No anti-tuberculosis treatment received within one month.\n* 5.For patients who don't have baseline sputum culture results,positive sputum smear and no effective anti-tuberculosis treatment administered\n* 6\\. No history of respiratory failure or heart failure, and no clinically significant manifestations of arrhythmia, with a QTcF under 450ms\n* 7.Promise to adhere to the treatment and follow-up schedule, complete treatment monitoring, and promptly report adverse reactions to the responsible physician\n* 8.Voluntarily participate in this study and sign the informed consent form\n\nExclusion Criteria\n\n* 1.According to DMID, peripheral neuropathy is classified as grade 3 or 4. Alternatively, participants with grade 1 or 2 neuropathy, which the investigator believes may progress\u002Fworsen during the study\n* 2.Elevation of ALT or AST ≥3 times the upper limit of normal, or elevation of total bilirubin and direct bilirubin ≥2 times the upper limit of normal\n* 3.Pregnant women or those who intent to pregnant during treatment\n* 4.Participants who have participated in other drug trials in the past three months\n* 5.Known congenital QT interval prolongation or any disease prolonging the QT interval, or QTc\\>450 ms\n* 6.History of symptomatic arrhythmias or clinically relevant bradycardia\n* 7.Any cardiac disease that could precipitate arrhythmias, such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure with decreased left ventricular ejection fraction\n* 8.History of known, untreated, persistent hypothyroidism\n* 9.Electrolyte disturbances, especially hypokalemia, hypocalcemia, or hypomagnesemia\n* 10.History of allergy or known allergic reactions to any investigational drug or related substances\n* 11.BMI\\\u003C17 kg\u002Fm2\n* 12.Karnofsky performance score under 50, or as determined by the principal investigator, the anticipated survival of the participant is not expected to exceed 6 months\n* 13.Participants expected to require surgical intervention following assessment of their pulmonary disease\n\nWithdrawal Criteria\n\n1. Serious adverse events caused by the intervention\n2. Confirmed QTcF interval ≥ 500ms or clinically significant ventricular arrhythmias\n3. The expert panel deems the continuation of this combination regimen inappropriate\n4. The patient requests withdrawal",{"count":78,"type":20},45,[80],"PHASE4","The goal of this investigator initiated trial (IIT) is to learn if a 6-9months BDL regimen (bedaquiline plus delamanid plus linezolid）works to treat adults with multi-drug resistant tuberculosis or rifampicin-resistant pulmonary tuberculosis, in the context of Pretomanid not available in China. It will also learn about the safety of BDL regimen.\n\nThe main questions it aims to answer are:\n\n1. What is the percentage of participants with favorable treatment outcome at the end of treatment?\n2. What are the frequency and degree of AE and SAE associated with BDL regimen?\n\nParticipants will take Bedaquiline +Delamanid+ Linezolid for 6 months, option for 9 months for subjects who remain culture positive at month 4 to 6. Safety and efficacy data will be monitored and collected during treatment. A 12 month follow-up will be conducted after treatment completion.",[27],"RECRUITING","2024-06-24",{"date":86,"type":39},"2024-06-26",{"date":88,"type":20},"2024-06",{"date":90,"type":20},"2026-06",{"name":45,"class":46},7,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100547128","phase-4-efficacy-safety-baidiziyin-shenqiyifei-adjunctive-treatments-pulmonary-tuberculosis-100547128","NCT06403943","Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis","A Randomized, Controlled, Multicenter Clinical Study on the Efficacy and Safety of BaiDiZiYin Pill and ShenQiYiFei Pill as Adjunctive Treatments for Newly Diagnosed Pulmonary Tuberculosis Patients","Inclusion Criteria:\n\n* 1\\. Age: 18 to 65 years old, regardless of gender;\n* 2\\. Meets the diagnostic criteria for Western medicine pulmonary tuberculosis (formulated in accordance with the health industry standard WS 288-2017 \"Diagnosis of Pulmonary Tuberculosis\" of the People's Republic of China \\[9\\])\n* 3\\. Have not received anti tuberculosis treatment in the past, or have received HRZE anti tuberculosis treatment for less than 1 week as a first-line option\n* 4\\. The subjects themselves have informed consent, voluntarily participate in this study, have good medication compliance, and have signed the subject's informed consent form.\n\nConforming to the diagnostic criteria for Qi and Yin deficiency syndrome in traditional Chinese medicine (in accordance with the industry standards of traditional Chinese medicine in the People's Republic of China - Traditional Chinese Medicine Internal Medicine - Diagnosis and Efficacy Criteria for Disease Symptoms ZY\u002FT0011.1-94) Main symptoms: shortness of breath, fatigue, mental fatigue, weak pulse Secondary symptoms: hemoptysis, spontaneous sweating, night sweating, insufficient appetite, bloating, red and tender tongue, thin coating Diagnosis can be made by having two main symptoms and one secondary symptom.\n\nExclusion Criteria:\n\n* 1\\. Patients who received similar traditional Chinese medicine treatment 4 weeks prior to enrollment;\n* 2\\. Patients with drug-resistant and extensively drug-resistant pulmonary tuberculosis;\n* 3\\. Known or suspected to have a history of allergies or serious adverse reactions to the investigational drug and its excipients, or allergic constitution.\n* 4\\. Patients with drug sensitivity indicating the growth of non tuberculosis mycobacteria (more than twice) or clinically diagnosed with non tuberculosis mycobacterial disease or concomitant non tuberculosis mycobacterial disease;\n* 5\\. For patients with recurrent pulmonary tuberculosis, those with bacterial negative pulmonary tuberculosis or those with initial bacterial positive pulmonary tuberculosis who have received anti tuberculosis treatment for more than one week;\n* 6\\. Patients with combined autoimmune diseases, malignant tumors, severe hematological and hematopoietic system diseases, epilepsy, and psychiatric disorders;\n* 7\\. Concomitant severe organic cardiovascular and cerebrovascular diseases (such as congestive heart failure, myocardial infarction, and acute stroke with NYHA heart function grading of III-IV);\n* 8\\. Merge uncontrolled hypertension (blood pressure ≥ 160\u002F100mmHg at enrollment);\n* 9\\. diabetes with poor glycemic control;\n* 10\\. Concomitant severe liver and kidney diseases, or abnormal liver and kidney function tests (ALT, AST ≥ 2.5 times the upper limit of normal, Scr\\>the upper limit of normal);\n* 11\\. Patients with extrapulmonary tuberculosis such as lymph node tuberculosis, intestinal tuberculosis, bone tuberculosis, renal tuberculosis, epididymal tuberculosis, urogenital tuberculosis, nervous system tuberculosis, and tuberculous meningitis;\n* 12\\. Concomitant with other lung diseases, such as lung tumors, cysts, abscesses, interstitial lung disease, silicosis, pneumoconiosis, etc\n* 13\\. Pregnant and lactating women;\n* 14\\. HIV patients; Syphilis antibody positive patients;\n* 15\\. Individuals who have participated in other clinical trials within 15.1 months;\n* 16\\. Those who suspect or have a history of alcohol or drug abuse or a tendency towards drug dependence;\n* 17\\. The researchers believe that patients are not suitable for inclusion in this trial.","65 Years",{"count":102,"type":20},292,[80],"This study is designed to further strengthen the clinical application evidence of BaidiZiyin Pill and ShenqiYifei Pill in the treatment of tuberculosis. To be included in the initial treatment of pulmonary tuberculosis patients, on the basis of standardized Western medicine treatment, BaidiZiyin Pills and ShenqiYifei Pills will be used to evaluate the clinical efficacy and safety of their products.\n\n1. Evaluate the improvement of symptoms in the adjuvant treatment of newly treated pulmonary tuberculosis with BaidiZiyin Pill and ShenqiYifei Pill.\n2. Explore the sputum negative conversion time and sputum negative conversion rate of BaidiZiyin Pill and ShenqiYifei Pill as adjunctive treatments for newly treated pulmonary tuberculosis.\n3. Explore the protective effects of BaidiZiyin Pill and ShenqiYifei Pill on adverse reactions caused by chemotherapy.",[106,107,28],"Adjuvant","Treatment","2024-05-03",{"date":110,"type":39},"2024-05-08",{"date":112,"type":39},"2023-05-29",{"date":114,"type":20},"2026-12-31",{"name":45,"class":46},1,""]