Hu He Hao Te Shi

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

Researchers are evaluating the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for treating B-cell lymphoma. This Phase II clinical trial focuses on patients diagnosed with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B-cell lymphoma DLBCL. The study aims to assess how well this combination therapy works and its overall safety. Participants will receive TQB3702 tablets at a dose of 200 mg every 4 weeks as one treatment cycle. Alongside this, they will undergo chemotherapy cycles every 3 or 4 weeks, with a total of 6 to 12 cycles of combination therapy. The chemotherapy regimen is designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, support immune function, and prevent new blood vessel formation that supports tumors. During the trial, participants will be closely monitored for treatment response and safety. Researchers will measure overall and complete response rates up to 2 years, as well as adverse events, progression-free survival, duration of response, and overall survival up to death from any cause. The study includes assessments from baseline through combination therapy completion and follow-up periods lasting up to 2 years. This comprehensive monitoring helps understand both the immediate and longer-term effects of the treatment.

Researchers are evaluating the safety and effectiveness of TQ05105 Tablets combined with TQB3617 Capsules in people with intermediate- and high-risk Myelofibrosis, a type of bone marrow cancer. This open, single-arm, multi-center clinical trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to find the best dose and measure improvements in spleen size and symptoms over time. Participants will take TQ05105 Tablets, which target Janus kinase 1 and 2 enzymes, together with TQB3617 Capsules, which inhibit bromodomain and extra-terminal proteins. Both medications are taken orally in 21-day treatment cycles. The study includes an initial phase to determine the maximum tolerated dose and recommended dose, followed by longer evaluation periods lasting up to 120 weeks. During the study, participants will undergo regular assessments including measurement of spleen volume, symptom questionnaires, gene mutation analysis, and monitoring of side effects. The main outcomes focus on spleen volume reduction and symptom improvement, as well as survival and safety over the study period. Total participation may last up to two years, with ongoing monitoring to evaluate treatment response and tolerability.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating a new oral synbiotic formula called SMT04 to see if it can reduce the recurrence of advanced adenomas and related bacterial gene markers in people who have had colorectal advanced neoplasia removed. The study is a multicenter, double-blinded randomized controlled trial focused on colorectal cancer and its precancerous lesions, exploring how gut microbiome changes may influence disease progression and recurrence. The trial seeks to understand if SMT04 can sustain long-term benefits in lowering harmful bacterial markers linked to colorectal neoplasia. Participants will be randomly assigned to receive either the SMT04 synbiotic formula, which combines probiotics and heat-resistant prebiotics, or an active placebo containing a small amount of vitamin C and inert starch filler with matching appearance and flavor. The trial includes a control group receiving the placebo to compare effects. The SMT04 formula has previously been shown to increase beneficial Bifidobacterium species and reduce certain bacterial gene markers over weeks 2 to 12, but its long-term impact is still being studied. During the year-long study, participants will undergo monitoring to detect any recurrence of advanced colorectal neoplasia through colonoscopies and bacterial gene marker measurements. Researchers will track the incidence and number of recurrent adenomas and advanced neoplasia, as well as changes in bacterial gene markers and their correlation with disease recurrence. The primary outcome is the incidence of recurrent advanced colorectal neoplasia at one year. The study involves regular assessments, including colonoscopy quality checks and histopathological confirmation, to ensure thorough evaluation of treatment effects.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying the use of molecular typing in the treatment of advanced thyroid cancer through a real-world clinical study that includes both retrospective and prospective parts. The retrospective study looks back at patients treated from January 2020 to December 2023 in 24 hospitals, gathering data on treatment history, molecular test results, adverse reactions, and survival outcomes. The prospective study will enroll patients from January 2024 to April 2027 receiving precise treatments in the same hospitals. This study aims to understand how molecular typing can guide treatment in various types of advanced thyroid cancer, including differentiated, medullary, poorly differentiated, and anaplastic forms. Participants receive targeted drug treatments based on the type of gene mutations found in their cancer. These treatments include dabrafenib plus trametinib for BRAF V600E mutation, entrectinib or larotrectinib for NTRK mutation, pralsetinib or selpercatinib for RET fusion or mutation, anlotinib for medullary carcinoma without RET mutation, lenvatinib combined with anti-PD-1 antibody for patients without specific mutations or unable to afford precision therapy, and other targeted treatments based on identified targets. The study includes several patient groups defined by cancer type and suitability for radioiodine therapy. During the study, researchers will collect and analyze clinical data, molecular test results, medication regimens, and follow-up survival information up to about three years. Key outcomes measured include objective response rate, duration and time to response, disease control rate, progression-free survival, and overall survival. Safety and adverse reactions are also monitored. The study involves ongoing data collection and follow-up to assess how molecularly guided treatments affect advanced thyroid cancer management over time.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating the safety, tolerability, drug levels, and early clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have tumors with a KRAS p.G12C mutation and a co-mutation in STK11, while having wild-type KEAP1. This trial includes patients who are either newly diagnosed or have received at least one prior treatment for advanced disease. The study is a Phase IbII, open-label, multi-center trial sponsored by Allist Pharmaceuticals, Inc. The study includes a Dose Escalation phase where JAB-21822 is given as a monotherapy to find the maximum tolerated dose MTD and recommended Phase 2 dose RP2D. After this, there are two Dose Expansion parts Part 1 tests safety and clinical activity in patients who have not been treated before, and Part 2 evaluates the same outcomes in patients who have had at least one previous systemic therapy. JAB-21822 is administered orally throughout the study. Participants will be monitored for dose-limiting toxicities and adverse events during the Dose Escalation phase and safety and clinical responses during the Dose Expansion phases for up to three years. Researchers will assess tumor responses using objective response rates and other measures like progression-free survival and overall survival. Drug plasma levels will also be tracked. This comprehensive monitoring includes regular clinical evaluations and follow-up to understand the drugs effects and safety over time.