Faridabad

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating the efficacy and safety of tozorakimab delivered under the skin in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb, double-blind, placebo-controlled study aims to find the optimal dosing range of tozorakimab in this population. The study is sponsored by AstraZeneca and uses a randomized, parallel design to compare different doses and placebo. Participants will receive subcutaneous injections of either tozorakimab at one of two dose levels or a placebo. The study arms include dosing with tozorakimab Dose 1, tozorakimab Dose 2, or placebo, administered under the skin. The treatment period lasts from 26 to 52 weeks, during which participants will be monitored for their asthma symptoms and lung function. Throughout the study, participants will undergo assessments including lung function tests such as forced expiratory volume in 1 second FEV1, asthma control questionnaires ACQ-6, quality of life questionnaires AQLQ12, and measurements of asthma exacerbations. Blood samples will be collected to measure drug levels and immune response. Safety and adherence will be closely monitored, and the primary outcome is the annualized rate of severe asthma exacerbations over the treatment period.

Researchers are evaluating the safety of using an abdominal drain versus no drain after donor hepatectomy in live liver donors. This pilot study aims to compare these two approaches by measuring the comprehensive complication index CCI at the time of hospital discharge. The CCI score reflects the overall complication burden on patients after surgery, ranging from 0 no complications to 100 death, and is a validated tool for living donor liver transplants. Participants will undergo donor hepatectomy and be randomly assigned to either the drain or no drain group. In the drain group, a 28 Fr abdominal drain will be placed near the cut surface of the liver remnant after confirming hemostasis and biliostasis. In the no drain group, the abdomen will be closed without placing a drain. Both groups will have intraoperative and post-operative parameters compared. During the study, participants will be admitted one day before surgery and monitored until post-operative day 7. Researchers will assess the CCI score on day 7 using an online calculator. Secondary outcomes include infective complications, hospital stay length, paralytic ileus, bile leak, hemorrhage, and pain scores. This thorough monitoring will help evaluate safety differences between the two approaches.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are observing the use of ImmunoglobulinHistamine Complex IHC, also known as Histoglob, in patients aged 13 years and older who have Chronic Urticaria in India. This real-world evidence study aims to assess how effective and safe Histoglob is for managing this condition, particularly in patients who are not controlled by first-line treatments like antihistamines. Participants in this observational study receive Histoglob injections, administered as a single 1 mL subcutaneous dose via prefilled syringe. The study focuses on patients who have been prescribed Histoglob for the first time as part of their routine care, without altering their usual treatment plans. There is no placebo or comparison group, as this is a non-interventional study following patients in real-world settings. During the approximately one-year study period, participants will be monitored for clinical improvement using the Urticaria Activity Score UAS7. Researchers will also track changes in antihistamine and other medication use, quality of life measures, and safety and tolerability throughout the study. Participants will continue their regular care while providing data through this observation to help evaluate Histoglobs role in managing Chronic Urticaria.

Researchers are evaluating intravenous BSG005 in patients with uncomplicated invasive fungal infections IFI in an open-label Phase 1b study. This single-arm, dose-escalation trial aims to assess the safety and efficacy of BSG005, enrolling approximately 15 patients in three cohorts. The study includes a Screening period, Treatment period, and Follow-up period, focusing on patients with IFI who may have failed or cannot tolerate first-line antifungal treatments. BSG005 will be administered daily via intravenous infusion over 120 minutes which may be extended to 240 minutes, with doses escalating depending on safety and efficacy assessments. Treatment starts at 0.1 mgkg in Cohort 1, increasing up to 1.0 mgkg over a maximum of 28 days. Subsequent cohorts may receive higher maximum doses up to 3.0 mgkg, adjusted by the investigator based on patient status. Central or long peripheral catheters are preferred due to the drugs potential for causing phlebitis. Participants will be in the study for up to 50 days, including a 7-day Screening period, baseline assessments, up to 28 days of treatment, and a 14-day follow-up. Researchers will monitor safety, tolerability, and overall response to treatment through clinical, mycological, and radiological evaluations. The primary outcome is to establish the safety and tolerability of BSG005, with secondary outcomes assessing treatment response during and after therapy.