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Sucrose

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.

Table of Contents

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.[1][3][5]

These studies are interventional, which means the researchers give a study treatment and then watch what happens.[1][2][3][4][5]

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.[3] 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.[3]

Another Phase 2 trial is studying children aged 1 to 5 years who are hospitalized with asthma-like symptoms.[6] 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.[6]

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.[3][6]

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.[1][2][4]

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.[2] 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.[2]

Another Phase 3 liver transplantation study also compares Custodiol-N with Custodiol and measures GPT (ALT) over 7 days after transplantation.[4] 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.[5]

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.[1]

Trial design, phases, and participation

Most of the studies are randomized, which means people are placed into study groups by chance.[1][2][3][5]

Several trials are single-blind, meaning that one side of the study does not know which treatment is given.[1][2][3][5]

The enrollment numbers range from 15 participants in the pediatric heart transplant study to 362 participants in the large transplant preservation study.[2][5] This shows that some studies are small and focused, while others are much larger and designed to compare treatment effects more broadly.[2][5]

The listed phases are Phase 2 and Phase 3, so the research includes both earlier safety-focused work and later comparative studies.[1][2][3][4][5][6]

Main outcomes being measured

The outcomes in these trials are practical measures of recovery and safety.[1][2][3][4][5][6]

  • Adverse events are unwanted medical problems reported during the study, and they are used to check safety after surgery or during follow-up.[1][5]

  • 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.[1]

  • Delayed graft function is the main kidney transplant endpoint in one study and means the new kidney does not start working right away.[2]

  • GPT (ALT) is a liver blood test measured over 7 days after transplantation to assess graft injury and recovery.[2][4]

  • Time to discharge is used in the wheezing study to measure how quickly the child is well enough to leave the hospital.[3]

  • Duration of the asthma-like episode is the main outcome in the hospitalized childhood asthma study.[6]

Study status and what it means

One pediatric cardiac surgery study is marked Suspended, which means it has been paused.[1]

The other studies are marked Authorised, which means they have been allowed to proceed in the listed setting.[2][3][4][5][6]

Overall, the trial data shows a mix of pediatric breathing studies and transplant studies, with outcomes centered on safety, recovery, and organ function.[1][2][3][4][5][6]

Trial ID Phase Condition studied Status Enrollment
2024-511517-38-00 Phase 2 Congenital heart malformation in children Suspended 100
2024-512444-29-00 Phase 3 Kidney, liver, or kidney-pancreatic transplantation Authorised 362
NCT05444699 Phase 3 Rhinovirus-induced wheezing in children less than 2 years of age Authorised 210
2023-510492-57-00 Phase 2 Heart transplantation in children Authorised 15
2024-518174-13-00 Phase 3 Liver transplantation Authorised 200
NCT05028153 Phase 2 Childhood asthma Authorised 320

FAQ

  • What kinds of clinical trials involving Sucrose are listed here? The trial data includes studies in children with wheezing or asthma-like symptoms and studies in transplant patients. Some trials compare solutions used for organ preservation, while others include Sucrose as part of an oral treatment plan.
  • Who can take part in the Sucrose trials? The target groups include children younger than 2 years, children aged 1 to 5 years, children having heart transplantation, and patients having kidney, liver, or pancreas-related transplantation. Each trial has its own age and condition rules.
  • What phases are the Sucrose trials in? The listed trials are in Phase 2 and Phase 3. Phase 2 studies often look closely at safety and early effects, while Phase 3 studies compare treatments in larger groups and measure key outcomes.
  • What are the trials trying to measure? The trials measure outcomes such as adverse events, time to discharge, graft function after transplantation, and markers of organ injury like CK-MB or GPT (ALT). These outcomes help show whether the study treatment is safe and effective.
  • Is Sucrose being studied for one disease only? No. In the trial data, Sucrose appears in studies for different conditions, including wheezing and asthma-like illness in children. It is also listed in a trial with other study drugs or solutions in transplant-related research.

Ongoing Clinical Trials on Sucrose

  • Study on Oral Prednisolone and Sucrose for Treating Wheezing Caused by Rhinovirus in Children Under 2 Years Old

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland

  • Study comparing Custodiol-N and Custodiol organ preservation solutions for heart transplantation in children

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Organ Preservation in Kidney, Liver, and Pancreas Transplants Using Custodiol-N Solution Compared to a Drug Combination for Transplant Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study on Azithromycin for Treating Hospitalized Children Aged 1-5 with Asthma Symptoms

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study Comparing Custodiol-N and Custodiol for Heart Surgery in Children with Congenital Heart Defects

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Liver Transplantation: Comparing Custodiol-N Solution with a Drug Combination for Organ Preservation in Patients Undergoing Liver Transplant Surgery

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Clinical trial: A research study in people that tests a treatment, a procedure, or a medical strategy.
  • Interventional study: A study where participants receive a treatment or procedure assigned by the researchers.
  • Phase 2: A mid-stage trial that often focuses on safety and early signs of benefit.
  • Phase 3: A later-stage trial that compares treatments in larger groups and checks how well they work.
  • Randomized: Participants are assigned by chance to different study groups.
  • Single-blind: One side of the study, usually the participant or the team, does not know which treatment is given.
  • Adverse events: Unwanted medical problems that happen during a study.
  • Myocardial protection: Protection of the heart muscle during surgery.
  • Graft function: How well a transplanted organ starts working after surgery.
  • Delayed graft function: When a transplanted organ does not start working right away.
  • AUC: Area under the curve, a way to measure a lab result over time.
  • CK-MB: A blood marker that can help show injury to the heart muscle.

References

  1. https://clinicaltrials.gov/study/2024-511517-38-00
  2. https://clinicaltrials.gov/study/2024-512444-29-00
  3. https://clinicaltrials.eu/trial/study-on-oral-prednisolone-and-sucrose-for-treating-wheezing-caused-by-rhinovirus-in-children-under-2-years-old/
  4. https://clinicaltrials.gov/study/2024-518174-13-00
  5. https://clinicaltrials.gov/study/2023-510492-57-00
  6. https://clinicaltrials.eu/trial/study-on-azithromycin-for-treating-hospitalized-children-aged-1-5-with-asthma-symptoms/