Europas førende søgning efter kliniske forsøg

Histidine

Clinical trials investigating Histidine are studying organ preservation and surgery support in transplant and pediatric heart surgery settings. The trials mainly compare Histidine-containing solutions with standard solutions to assess safety, graft or heart protection, and recovery outcomes in children and adults undergoing transplantation or major surgery.

Table of contents

Overview of the Histidine trials

The trial data show studies that investigate Histidine in the setting of organ preservation and surgery support, mainly through comparison with Custodiol or Custodiol-N solutions.[1][2][3][4]

These studies are not about general use of Histidine as a medicine in everyday care. They are focused on whether the study solutions help protect organs or improve recovery during and after major operations.[1][2][4]

Who the studies are for

The target groups include patients who will undergo kidney, liver, or kidney-pancreas transplantation.[1]

One study is for children undergoing heart transplantation, and another is for children with congenital heart malformation who need cardiac surgery.[2][3]

Other studies focus on adults after oesophagectomy and major emergency abdominal surgery.[4][5]

Trial phases and study design

The data include both Phase 2 and Phase 3 studies.[1][2][3][4][5]

Phase 2 studies are smaller and usually look closely at safety, while Phase 3 studies are larger and compare study treatments in more people.[2][3][1][4][5]

Several studies are described as prospective, randomized, single blind, and multicenter, which means they follow patients forward in time, assign treatment by chance, hide the treatment from one side of the study, and run at more than one hospital.[1][2][3]

What the studies measure

The kidney and liver transplant study measures delayed graft function for kidney transplants and the area under the curve of GPT (ALT) for liver transplants over the first 7 days after implantation.[1]

The pediatric heart transplant study measures safety by continuous adverse event reporting for up to 3 months.[2]

The congenital heart surgery study also focuses on safety, with continuous adverse event reporting up to 30 days after surgery, and on myocardial protection, measured by CK-MB levels until day 7 after surgery.[3]

The liver transplantation study measures GPT (ALT) over 7 days after transplantation and compares the area under the curve between the two study groups.[4]

The oesophagectomy study looks at changes in muscle size on CT scan from before surgery to 10 days after surgery.[5]

The emergency abdominal surgery study measures whether early or postponed supplementary parenteral nutrition lowers infectious complications during the hospital stay.[6]

Key trial details

Trial 2024-512444-29-00 is a Phase 3 study in 362 patients undergoing kidney, liver, or kidney-pancreas transplantation. It compares Custodiol-N with Custodiol and aims to show that graft preservation with Custodiol-N is not worse than the comparison solution for graft function and injury after transplantation.[1]

Trial 2023-510492-57-00 is a Phase 2 pediatric heart transplant study with 15 participants. It compares Custodiol-N with Custodiol and focuses on safety during the first 3 months after treatment.[2]

Trial 2024-511517-38-00 is a Phase 2 study in 100 children with congenital heart malformation. It compares two methods of cardioplegia, which means heart protection during surgery, and it is suspended.[3]

Trial 2024-518174-13-00 is a Phase 3 liver transplantation study with 200 participants. It compares Custodiol-N with Custodiol solution for organ preservation and measures GPT (ALT) over 7 days after transplant.[4]

Trial 2023-507649-27-00 is a Phase 3 study with 38 participants after oesophagectomy. It examines how the route of nutrition affects muscle wasting, using CT scan measurements of muscle size.[5]

Trial 2023-505378-14-00 is a Phase 3 study with 342 participants after major emergency abdominal surgery. It compares early and postponed supplementary parenteral nutrition and looks at infection rates during admission.[6]

Study status and enrollment

Most of the trials in the data are authorised, which means they have been approved to run.[1][2][4][5][6]

One study is suspended, so it is not currently continuing as planned.[3]

The enrollment numbers range from 15 children in the pediatric heart transplant study to 362 patients in the large transplant study, showing that the research includes both small and larger patient groups.[2][1]

Trial IDPhaseCondition studiedStatusEnrollment
2024-512444-29-00Phase 3Kidney, liver, and kidney-pancreas transplantationAuthorised362
2023-510492-57-00Phase 2Heart transplantation in childrenAuthorised15
2024-511517-38-00Phase 2Congenital heart malformation in childrenSuspended100
2024-518174-13-00Phase 3Liver transplantationAuthorised200
2023-507649-27-00Phase 3OesophagectomyAuthorised38
2023-505378-14-00Phase 3Major emergency abdominal surgeryAuthorised342

FAQ

  • What kinds of clinical trials are studying Histidine? The trials are testing Histidine in organ preservation and heart surgery settings. They compare Histidine-containing solutions with other solutions to see how well they protect organs and how safe they are.
  • Who can take part in these Histidine trials? The target groups include adults and children undergoing kidney, liver, pancreas, or heart transplantation, as well as children with congenital heart malformations and patients after major emergency abdominal surgery. Each study has its own eligibility rules.
  • What phases are the Histidine trials in? The trial data include Phase 2 and Phase 3 studies. Phase 2 studies focus more on safety, while Phase 3 studies look at larger comparisons and treatment effects.
  • What are the researchers measuring in these studies? The studies measure outcomes such as safety, delayed graft function, liver injury markers, heart muscle protection, infection rates, and muscle loss. These outcomes help show whether the study solution works better or is as good as the comparison solution.
  • Are all the Histidine trials active? No. Some studies are authorised, while one listed study is suspended. This means the research status is not the same across all trials.

Igangværende kliniske forsøg for Histidine

  • Sammenligning af Custodiol-N og Custodiol præservationsopløsninger ved hjertetransplantation hos børn: Et fase II sikkerhedsstudie

    Rekrutterer

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tyskland

  • Sammenligning af Custodiol-N og Custodiol væsker til beskyttelse af organer under nyre-, lever- eller bugspytkirtel-transplantation

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Østrig

  • Sammenligning af to hjertebeskyttende væsker (Custodiol-N og Custodiol) under operation af børn med medfødt hjertefejl

    Rekrutterer endnu ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tyskland

  • Undersøgelse af hvordan forskellige ernæringsformer påvirker muskeltab efter operation i spiserøret

    Rekrutterer endnu ikke

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Danmark

  • Sammenligning af tidlig eller sen ekstra ernæring gennem drop efter akut maveoperation

    Rekrutterer ikke

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Danmark

  • Sammenligning af Custodiol-N og Custodiol væsker til beskyttelse af donorlevere under levertransplantation

    Rekrutterer ikke

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Spanien

Ordliste

  • Clinical trial: A planned research study in people that tests whether a treatment or procedure is safe, useful, or better than another option.
  • Interventional study: A study where researchers actively give a treatment or procedure and then observe the results.
  • Phase 2: An earlier study phase that usually focuses on safety and early signs that a treatment may work.
  • Phase 3: A larger study phase that compares treatments in more people to confirm safety and effectiveness.
  • Randomized: Participants are assigned by chance to different study groups, which helps make the comparison fair.
  • Single blind: A study design where one group, often the participant, does not know which treatment is being given.
  • Multicenter: A study carried out at more than one hospital or research site.
  • Organ preservation: Methods used to keep an organ in good condition before it is transplanted.
  • Graft function: How well a transplanted organ works after surgery.
  • Delayed graft function: A delay in how soon a transplanted organ starts working properly, especially after kidney transplant.
  • AUC: Area under the curve, a way to measure a value over time, such as liver enzyme levels after transplant.
  • CK-MB: A blood marker that can rise when the heart muscle is injured.

Referencer

  1. https://clinicaltrials.gov/study/2024-512444-29-00
  2. https://clinicaltrials.gov/study/2023-510492-57-00
  3. https://clinicaltrials.gov/study/2024-511517-38-00
  4. https://clinicaltrials.gov/study/2024-518174-13-00
  5. https://clinicaltrials.gov/study/2023-507649-27-00
  6. https://clinicaltrials.gov/study/2023-505378-14-00