An observational study in Liver Failure, sponsored by Chiesi Hungary Ltd.. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Chiesi Hungary Ltd. (part of Chiesi Farmaceutici S.p.A.) · Observational
The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question[s] it aims to answer are:
Participants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care
The primary aim of the study is to assess tolerability of LCPT and graft function within the 24-month observational period. Other objectives include the assessment of the intraindividual variability of the TL and TDD, the incidence of BK and cytomegalovirus infections, the incidence of graft insufficiency and acute and chronic graft rejection. There are few real-life studies available on maintenance treatment regimens in liver transplant patients throughout Europe, and these only focus on the healthcare resources' consumption. There is a lack of data describing the effectiveness of different drugs and their combinations in early maintenance immunosuppression in the real-life setting. Even less data is available of ISU (immunosuppression) drugs combinations' metabolism and its relation to effectiveness and safety, measured in liver transplant patients.
Given the above considerations we planned this non-interventional study (NIS) to assess pharmacokinetic parameters of LCPT and other tacrolimus containing medications and their relation to efficacy and tolerability in hepatic allograft recipients in a real-life setting.
190 studies on the registry are indexed under Liver Failure; 33 are open to participants now.
This study's planned enrollment of 110 is below the median of 129 across 66 observational studies indexed under Liver Failure.
Browse Liver Failure studies →Chiesi Hungary Ltd. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult, liver (or concomittant liver-renal) transplant patients, receiving tacrolimus containing medications.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of the following comorbidities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Patients ≥ 18 years of age 2. Patients after liver- or simultaneous liver and kidney transplantation 3. Having received a tacrolimus containing immunosuppressant therapeutic regimen at least for four weeks (induction therapy), and TL is within 5-20 ng/ml before inclusion. Possible medications are the following (dosages and administration according to local (European) SmPC * Envarsus prolonged release tablet * Adport hard capsule * Advagraf prolonged-release hard capsule * Modigraf granule for oral suspension * Prograf hard capsule * Tacforius hard capsule
Drug: Tacrolimus
Tacrolimus received as part of routine clinical care
Pharmacokinetic profile TL
To compare the trough level (TL) of different tacrolimus containing medications to Envarsus at each visit
Time frame: 12 months
Pharmacokinetic profile TDD
To compare the total daily dose (TDD) of different tacrolimus containing medications to Envarsus at each visit
Time frame: 12 months
Pharmacokinetic profile C/D
To compare the ration of TL and TDD (C/D) of different tacrolimus containing medications to Envarsus at each visit
Time frame: 12 months
Liver function GGT
Changes in Gamma glutamine transferase (GGT) levels compared to baseline.
Time frame: 12 months
Liver function AP
Changes in Alcalic phosphatase (AP) levels compared to baseline.
Time frame: 12 months
Liver function GOT
Changes in Glutamyl oxaloacetic transaminase (GOT) levels compared to baseline.
Time frame: 12 months
Liver function GPT
Changes in Glutamyl pyruvic transaminase (GPT) levels compared to baseline.
Time frame: 12 months
Renal function
Change in the estimated glomerular filtration rate (eGFR) compared to baseline.
Time frame: 12 months
Kinetics and function
To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage)
Time frame: 12 months
Rejection
Incidence of acute graft rejection during the study
Time frame: 12 months
Virus infection
Incidence of BK and cytomegalovirus (CMV) infection during the study
Time frame: 12 months
Variability
To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D)
Time frame: 12 months
Adherence BAASIS
To assess the patient-adherence of therapy based on the BAASIS questionnaire
Time frame: 12 months
Adherence prescriptions
To assess the patient-adherence of therapy based on the prescription filled by individual patients, based on electronic health-care record.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Mar 2026, 33 months after the start.
Of 25 observational studies under Liver Failure, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 127. This study's planned 33 months is below that.
How these figures are worked out, and which studies are left out of them.
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