In short
Clinical trials involving Sucrose are studying it as part of different treatment plans in children and transplant patients. These studies look at safety, treatment effects, and recovery outcomes in conditions such as wheezing, asthma-like illness, and organ transplantation. The trial data below explains who is being studied, what phases the trials are in, and what results are being measured.
Key points
- Sucrose appears in clinical trial data for several different studies, including pediatric breathing problems and transplant-related research. The studies are in Phase 2 and Phase 3, which means they are checking safety, early benefit, and larger comparisons. Some trials focus on children with wheezing or asthma-like symptoms, while others study organ preservation in kidney, liver, pancreas, and heart transplantation. The main outcomes include adverse events, time to discharge, graft function, and lab markers such as CK-MB and GPT (ALT). The target populations are mostly children, but some trials also include transplant patients. One trial is suspended, while the others are authorised.
Overview of the Sucrose trials
The trial data shows Sucrose in studies that are not all about the same disease. Some trials use Sucrose in children with wheezing or asthma-like symptoms, while other trials list Sucrose in studies about organ preservation during transplantation.
These studies are interventional, which means the researchers give a study treatment and then watch what happens.
Studies in children with breathing problems
One Phase 3 trial is studying children aged 6 months to 2 years who have acute wheezing caused by rhinovirus or another picornavirus, which is a group of viruses linked to colds and breathing symptoms. This study includes Sucrose as one of the oral study drugs and measures the time from study entry until the child is ready for discharge.
Another Phase 2 trial is studying children aged 1 to 5 years who are hospitalized with asthma-like symptoms. In that study, Sucrose is listed among the oral study materials, and the main outcome is the duration of the asthma-like episode after randomization.
These studies focus on short-term recovery in young children, especially how long the illness lasts and how quickly the child can leave the hospital.
Studies in transplant patients
Several trials study organ preservation solutions in transplantation, and Sucrose is not the main named comparison in those studies, but the trial data is part of the overall set provided here.
One Phase 3 study compares Custodiol-N with Custodiol in kidney, liver, and kidney-pancreatic transplantation, with the goal of showing non-inferiority, meaning that the new solution is not worse than the standard one by an important amount. The main outcomes include delayed graft function for kidney transplants and GPT (ALT) area under the curve for liver transplants over the first 7 days.
Another Phase 3 liver transplantation study also compares Custodiol-N with Custodiol and measures GPT (ALT) over 7 days after transplantation. A Phase 2 pediatric heart transplantation study compares Custodiol-N with Custodiol and focuses on safety with continuous adverse event reporting up to 3 months.
There is also a Phase 2 study in children having cardiac surgery for congenital heart malformation, where the main goals are safety and myocardial protection, measured by adverse events and CK-MB levels after surgery.
Trial design, phases, and participation
Most of the studies are randomized, which means people are placed into study groups by chance.
Several trials are single-blind, meaning that one side of the study does not know which treatment is given.
The enrollment numbers range from 15 participants in the pediatric heart transplant study to 362 participants in the large transplant preservation study. This shows that some studies are small and focused, while others are much larger and designed to compare treatment effects more broadly.
The listed phases are Phase 2 and Phase 3, so the research includes both earlier safety-focused work and later comparative studies.
Main outcomes being measured
The outcomes in these trials are practical measures of recovery and safety.
- Adverse events are unwanted medical problems reported during the study, and they are used to check safety after surgery or during follow-up.
- CK-MB is a blood marker used in the cardiac surgery study to assess myocardial protection, meaning how well the heart muscle is protected during surgery.
- Delayed graft function is the main kidney transplant endpoint in one study and means the new kidney does not start working right away.
- GPT (ALT) is a liver blood test measured over 7 days after transplantation to assess graft injury and recovery.
- Time to discharge is used in the wheezing study to measure how quickly the child is well enough to leave the hospital.
- Duration of the asthma-like episode is the main outcome in the hospitalized childhood asthma study.
Study status and what it means
One pediatric cardiac surgery study is marked Suspended, which means it has been paused.
The other studies are marked Authorised, which means they have been allowed to proceed in the listed setting.
Overall, the trial data shows a mix of pediatric breathing studies and transplant studies, with outcomes centered on safety, recovery, and organ function.