Ongoing Clinical Trials for Pulmonary Alveolar Haemorrhage
There is currently 1 ongoing clinical trial for pulmonary alveolar haemorrhage, a serious condition involving bleeding in the tiny air sacs of the lungs. This trial is investigating a new treatment approach for patients with severe lung bleeding caused by ANCA-associated vasculitis, a condition where the immune system attacks the body’s own blood vessels.
Clinical trial locations
Study on Imlifidase for Patients with Severe ANCA-Associated Vasculitis and Lung Bleeding
This clinical trial is investigating a treatment called Idefirix, which contains the active substance imlifidase, for patients with a specific type of blood vessel inflammation called ANCA-associated vasculitis that has led to severe bleeding in the lungs.
Who can participate:
- Patients with a confirmed diagnosis of ANCA-associated vasculitis, including conditions such as granulomatosis with polyangiitis or microscopic polyangiitis
- Those with a high ANCA antibody level (50 or higher) measured within the past 14 days
- Patients experiencing lung bleeding due to active vasculitis, confirmed by chest imaging showing specific lung patterns
- Evidence of bleeding must be present, such as blood in the lungs seen during bronchoscopy, coughing up blood, unexplained anemia, or acute respiratory distress syndrome
- Female participants must be post-menopausal, with no menstrual periods for at least 12 months
- Participants must be able to follow the study procedures and provide written informed consent
Who cannot participate:
- Patients with other serious medical conditions that might interfere with the study
- Pregnant or breastfeeding women
- Those who participated in another clinical trial within the last 30 days
- Patients with known allergies to the study medication or its ingredients
- Those with a history of drug or alcohol abuse within the past year
- Patients with severe liver or kidney disease
- Those with active infections requiring treatment
- Patients with a history of cancer within the last 5 years, except for certain skin cancers
- Those unable to follow study procedures or with a history of not complying with medical treatments
What the trial involves:
The study aims to evaluate how effective Idefirix is when used alongside standard care for severe ANCA-associated vasculitis with lung bleeding. Participants will receive either Idefirix or a placebo through an intravenous infusion, meaning the medication is delivered directly into the bloodstream through a vein. The trial will monitor how quickly ANCA antibody levels decrease after treatment, typically within 24 hours of administration.
Researchers will closely track various health outcomes, including lung and kidney function, overall safety, and any potential side effects. Regular check-ups and tests will be conducted throughout the study to assess response to treatment. The medication works by breaking down specific proteins in the immune system that are involved in causing inflammation and damage to blood vessels.
Investigational drug:
Imlifidase is an enzyme-based therapy that specifically targets the immune system to reduce inflammation and damage caused by ANCA-associated vasculitis. It is designed to help alleviate symptoms and improve patient outcomes by breaking down the antibodies responsible for attacking the body’s blood vessels.
The trial is expected to continue until mid-2026, with recruitment of participants starting in 2024.
Summary
Currently, there is one clinical trial available for patients with pulmonary alveolar haemorrhage related to ANCA-associated vasculitis. This trial is being conducted in Germany and focuses on testing imlifidase, a novel treatment approach that targets the immune system’s role in causing blood vessel inflammation and lung bleeding. The study represents an important step in understanding whether this enzyme-based therapy can provide additional benefits when combined with standard care for this serious condition. Patients interested in participating should discuss their eligibility with their healthcare provider, particularly regarding the specific diagnostic criteria and health requirements outlined in the trial.