A study organ preservation with Custodiol-N solution compared with Custodiol solution in liver trasnplantation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dr. Franz Koehler Chemie GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

24 Oct 2024 → ongoing

Decision date (initial)

2024-10-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Dr. Franz Köhler Chemie GmbH

External identifiers

EU CT number

2024-518174-13-00

EudraCT number

2019-001872-12

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the area under the curve (AUC) GPT (ALT) after transplantation during 7 days

Secondary objectives 6

1. To evaluate the absolute peak LDH within 7 days after transplantation
2. To evaluate the initial poor function, defined as one or more of the following laboratory parameters: bilirubin ≥ 10 mg/dl on Day 7 after the surgery; INR ≥ 1.6 on Day 7 after the surgery; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2000 IU/L within the first 7 days after the surgery (Olthoff criteria)
3. To evaluate the moment (day) of peak GPT and peak LDH
4. To evaluate the serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months and 6 months
5. To evaluate the biliary complications: number of episodes of cholestasis, therapy for cholangitis, episodes of biliary leakage and intrahepatic and/or extrahepatic biliary strictures.
6. To compare liver transplants with extended criteria donors (ECD) and DCD donors with both preservation solutions.

Conditions and MedDRA coding

Liver transplantation

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Recipients awaiting their first transplant
2. Recipients ≥18 years
3. Recipient's signed informed consent of data use and protection before the transplantation
4. Full organ transplantation

Exclusion criteria 5

1. Pregnant or lactating patients
2. Recipients participating in any interventional study (e.g. another study involving compound/interventions aimed at the reduction of preservation and/or ischemia/reperfusion injury)
3. All combined transplantations other than pancreas and kidney
4. High urgency patients
5. Patients in need of a retransplant

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Area under the curve (AUC) GPT (ALT) after transplantation during 7 days: with each liver transplant patient enrolled in the study, GPT will be measured once per day during the first 7 days, according to the standard practice of the center laboratory. Area under the curve will be analysed for this variable comparing Custodiol and Custodiol-N groups

Secondary endpoints 10

1. Absolute peak LDH within 7 days after transplantation: the highest peak of lactate-dehydrogenase within 7 days after transplantation according to the practice of the site laboratory
2. Olthoff criteria: bilirubin, international normalized ratio of prothrombin (INR). The Olthoff criteria will be applied to evaluate initial poor function when one or more of the following parameters would be present: Bilirubin ≥ 10 mg/dl on Day 7 after the surgery; INR ≥ 1.6 on Day 7 after the surgery; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2000 IU/L within the first 7 days after the surgery
3. MEAF score (Model for early allograft dysfunction)
4. Evaluation of the moment (day) of peak GPT and peak LDH: the highest daily peak GPT and peak LDH will be evaluated for comparisons between groups
5. Evaluation of the serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months and 6 months: these parameters will be measured at 3 months and 6 months after liver transplantation according to the references values of the site laboratory
6. Number of episodes of cholestasis
7. Therapy for cholangitis
8. Episodes of biliary leakage and intrahepatic and/or extrahepatic biliary strictures
9. Comparison in Extended Criteria Donors: the influence of Custodiol-N in liver transplants with ECD and DCD donors will be compared. ECD donors are defined as high risk donors with a donor risk index (DRI) higher than 1.7
10. Comparison in DCD donors: DCD donors are defined as donation after circulatory death donors and will be compared in liver transplants with Custodiol and Custodiol-N

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dr. Franz Koehler Chemie GmbH

Sponsor organisation

Dr. Franz Koehler Chemie GmbH

Address

Werner-Von-Siemens-Strasse 14-28

City

Bensheim

Postcode

64625

Country

Germany

Scientific contact point

Organisation

Dr. Franz Koehler Chemie GmbH

Contact name

Roman Petrov

Public contact point

Organisation

Dr. Franz Koehler Chemie GmbH

Contact name

Roman Petrov

Third parties 4

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications