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Found 6 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating AZD8965 in a Phase IIb trial to study its safety, tolerability, and effectiveness in treating Idiopathic Pulmonary Fibrosis IPF. The study compares three doses of AZD8965 to a placebo in participants with IPF, including those who are on stable doses of approved antifibrotic therapies such as nintedanib, pirfenidone, or nerandomilast, as well as those not taking antifibrotic treatment. The trial is randomized, placebo-controlled, double-blind, and parallel-group in design. Participants are assigned to one of four groups placebo, low dose AZD8965, medium dose AZD8965, or high dose AZD8965. The treatment lasts for 24 weeks, during which participants receive their assigned medication. The study includes approximately 360 participants across around 200 sites worldwide. Researchers aim to assess the clinical efficacy of AZD8965 by measuring changes in lung function and study the relationship between dose and outcomes. During the study, participants will undergo various assessments including lung function tests such as forced vital capacity FVC, monitoring for adverse events, and pharmacokinetic analyses of AZD8965. Safety and tolerability are monitored up to 25 weeks. Researchers will also track any serious adverse events and treatment discontinuations. The total participation time covers the 24-week treatment period with scheduled visits to assess the study outcomes and participant health.
Actively Recruiting
This research is focused on adults aged 40 and older who have idiopathic pulmonary fibrosis IPF, a lung condition characterized by scarring and reduced lung function. The study aims to evaluate whether the medicine BI 765423 can improve lung capacity compared to a placebo. Participants must have certain lung function levels and evidence of lung fibrosis confirmed by imaging to join the study. Participants are randomly assigned to one of two groups one receives BI 765423 through an intravenous infusion every four weeks, and the other receives a placebo that looks the same but contains no active medicine. The study lasts up to 11 months, during which participants may continue their standard IPF treatments. The main treatment period focuses on observing changes in lung function over 3 to 6 months. During the trial, participants visit the study site several times for screening, treatment, and follow-up assessments. Doctors measure lung function with tests like forced vital capacity FVC and collect blood samples to monitor markers of lung health. The study compares results between the groups to assess the effects of BI 765423, while also monitoring participants overall health and any side effects.
Actively Recruiting
Researchers are studying adults aged 40 years or older who have at least one family member with pulmonary fibrosis, a condition that causes scarring in the lungs and makes breathing difficult. The trial aims to find out if a drug called nerandomilast can slow lung changes in people showing early lung abnormalities on scans. This study is a Phase 3 clinical trial involving participants who have early signs of lung scarring and a family history of pulmonary fibrosis. Participants are randomly assigned to one of two groups one group takes nerandomilast tablets, and the other takes placebo tablets that look the same but contain no medicine. They take a tablet twice daily for about 2 to 3 years. During the study, there is a 60% chance a participant will receive nerandomilast. The trial lasts approximately 2 to 3 years, with more frequent visits every three months during the first two years and then every six months, plus phone calls in the third year. Throughout the study, doctors regularly test lung function and perform chest scans to monitor lung changes and the effects of treatment. Health status and any unwanted effects are also checked. The main outcome measured is the time to worsening of lung abnormalities over the trial period. Participants will be followed closely with lung function tests, imaging, and health assessments to understand the impact of nerandomilast compared to placebo.
Actively Recruiting
This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.
Actively Recruiting
Researchers are evaluating the overall survival of patients with stage I epithelial ovarian cancer after they have undergone comprehensive staging surgery. This phase III trial compares the outcomes of adjuvant chemotherapy versus observation alone. The study aims to determine whether adding chemotherapy after surgery improves survival in this patient group. Participants will be randomly assigned to one of two groups. One group receives adjuvant chemotherapy, which includes either a combination of paclitaxel and carboplatin or docetaxel and carboplatin, given every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. The other group undergoes observation without chemotherapy. During the study, participants will be monitored for overall survival up to 60 months from randomization. Researchers will also assess relapse-free survival within the same timeframe. Evaluations include follow-ups to track disease progression, side effects, and general health. The study ensures participants receive appropriate care and measures outcomes to better understand treatment benefits and risks.