#1 Clinical Trials Search in Europe

Human Plasma Gelsolin, Recombinant

This article discusses a clinical trial investigating the use of recombinant human plasma gelsolin (rhu-pGSN) as a potential treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) caused by pneumonia or other infections. The study aims to assess the safety and effectiveness of this drug when used alongside standard care in patients with ARDS.

Table of Contents

What is Recombinant Human Plasma Gelsolin (rhu-pGSN)?

Recombinant Human Plasma Gelsolin (rhu-pGSN) is a new medication being studied for the treatment of Acute Respiratory Distress Syndrome (ARDS). It’s also known by other names such as B2988 or simply “gelsolin”.[1] This drug is a protein that is made in a laboratory to mimic a naturally occurring protein in our blood called plasma gelsolin.

rhu-pGSN comes in the form of a powder that is mixed into a solution and given to patients through an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein.[1]

What is Acute Respiratory Distress Syndrome (ARDS)?

Acute Respiratory Distress Syndrome (ARDS) is a serious lung condition that causes difficulty breathing. It can occur when an infection, such as pneumonia, triggers inflammation in the lungs. This inflammation can cause fluid to build up in the tiny air sacs (alveoli) in the lungs, making it hard for oxygen to get into the blood.[1]

ARDS can be life-threatening and often requires patients to be put on a ventilator (a machine that helps with breathing) in an intensive care unit (ICU).

How rhu-pGSN Works for ARDS

While the exact way rhu-pGSN works is still being studied, researchers believe it may help reduce inflammation in the lungs and improve oxygen levels in the blood of patients with ARDS. By mimicking the natural gelsolin in our bodies, it might help to control the body’s immune response and reduce the damage caused by excessive inflammation.[1]

Current Clinical Trial for rhu-pGSN

A clinical trial is currently underway to test the effectiveness and safety of rhu-pGSN for treating moderate to severe ARDS caused by pneumonia or other infections. This is a Phase 2 trial, which means it’s designed to gather more information about how well the drug works and what side effects it might have.[1]

The main goal of this trial is to see if adding rhu-pGSN to standard care treatments can improve outcomes for patients with ARDS compared to standard care alone.[1]

Who Can Participate in the Trial?

The trial is looking for adult patients (18 years or older) who have moderate to severe ARDS due to an infection. Some key eligibility criteria include:

  • Having ARDS for 48 hours or less
  • Needing help with breathing (either through a ventilator, non-invasive ventilation, or high-flow oxygen)
  • Having clear signs of an infection that led to ARDS[1]

However, some conditions may prevent participation, such as:

  • Heart failure or other heart conditions contributing to breathing problems
  • Certain types of infections (like fungal or parasitic infections)
  • Pregnancy or breastfeeding
  • Recent organ transplants or active cancer treatments[1]

What Happens During the Trial?

If a patient is eligible and agrees to participate in the trial, they will be randomly assigned to receive either rhu-pGSN or a placebo (a substance with no active ingredients) in addition to their standard care treatment. Neither the patient nor their doctor will know which one they’re receiving.[1]

Participants will receive six doses of either rhu-pGSN or placebo through an IV infusion. Throughout the trial, doctors will closely monitor the patient’s condition, including how well they’re breathing and any potential side effects.[1]

Potential Benefits and Risks

The potential benefits of rhu-pGSN for ARDS patients could include:

  • Improved survival rates
  • Faster recovery from ARDS
  • Less time needing a ventilator or other breathing support
  • Shorter stays in the ICU and hospital[1]

However, as with any new medication, there may be risks or side effects that are not yet known. The trial is designed to carefully monitor for any adverse effects to ensure patient safety.[1]

It’s important to note that this medication is still in the testing phase, and more research is needed to fully understand its effectiveness and safety for treating ARDS.

Aspect Details
Study Type Phase 2, Randomized, Double-blind, Placebo-controlled
Condition Moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) due to pneumonia or other infections
Intervention Recombinant Human Plasma Gelsolin (rhu-pGSN) plus standard of care
Control Placebo plus standard of care
Primary Outcome All-cause mortality at Day 28
Key Secondary Outcomes Ventilator-free days, mortality at Day 60, time to discontinuation of respiratory support
Eligibility Age ≥18 years, moderate-to-severe ARDS (P/F ratio ≤150), evidence of infection
Treatment Duration 6 doses
Follow-up Period Up to 60 days

FAQ

  • What is the purpose of this clinical trial? The main purpose of this trial is to evaluate if intravenous recombinant human plasma gelsolin (rhu-pGSN), when used with standard care, is safe and beneficial for treating moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) caused by pneumonia or other infections.
  • Who can participate in this study? Participants must be at least 18 years old, have moderate-to-severe ARDS due to pneumonia or other infections, and meet specific criteria related to their condition. Some exclusions apply, such as having certain underlying health conditions or recent participation in other clinical trials.
  • How is the drug administered in this trial? The drug is given as an intravenous infusion. Participants will receive either rhu-pGSN or a placebo in addition to standard care for ARDS. The study involves 6 doses of the treatment.
  • What are the main outcomes being measured? The primary outcome is all-cause mortality at Day 28. Secondary outcomes include ventilator-free days, mortality at Day 60, time to discontinuation of respiratory support, and various safety measures.
  • How long does the study last for each participant? The study involves a screening period, followed by a treatment period with 6 doses of the study drug. Participants will be monitored for up to 60 days to assess outcomes and safety.

Ongoing Clinical Trials on Human Plasma Gelsolin, Recombinant

  • Study on the Safety and Benefits of Recombinant Human Plasma Gelsolin for Patients with Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS)

    Recruiting

    2 1
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Hungary +4

Glossary

  • Acute Respiratory Distress Syndrome (ARDS): A serious lung condition where fluid builds up in the air sacs, making it difficult to breathe. It often occurs as a complication of severe infections or injuries.
  • Recombinant Human Plasma Gelsolin (rhu-pGSN): A lab-made version of a protein naturally found in human blood. In this study, it's being tested as a potential treatment for ARDS.
  • Standard of Care (SOC): The typical treatment currently used for a specific condition. In this study, participants receive either rhu-pGSN or placebo in addition to standard care for ARDS.
  • Placebo: A substance that looks like the study drug but contains no active ingredient. It's used to compare the effects of the real drug.
  • Intubation: The process of inserting a tube through the mouth and into the airway to help a patient breathe.
  • Mechanical Ventilation: The use of a machine to help a patient breathe when they can't breathe effectively on their own.
  • P/F Ratio: A measure of lung function, calculated by dividing the arterial oxygen pressure by the fraction of inspired oxygen. A lower ratio indicates more severe lung problems.
  • Ventilator-Free Days: The number of days a patient can breathe without the help of a ventilator, used to measure improvement in breathing ability.
  • Extracorporeal Membrane Oxygenation (ECMO): A life support technique that oxygenates blood outside the body when the lungs can't function properly.
  • Adverse Event (AE): Any unfavorable medical occurrence in a patient during a clinical study, whether it's related to the study treatment or not.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-benefits-of-recombinant-human-plasma-gelsolin-for-patients-with-moderate-to-severe-acute-respiratory-distress-syndrome-ards/