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Liver TransplantationPhase 4NCT03423225

To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

A Phase 4 study testing ADVAGRAF® in people with Liver Transplantation, run by Kim, Seoung-Hoon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Liver Transplantation
What is being tested?
ADVAGRAF®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
No sites listed yet
Study dates
22 Mar 2016to 14 Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • When the Subjects agree informed consent form, Subject should be More than 20 years of age
  • Those who was transplanated liver at a minimum of 10 weeks or Maximum of 14 weeks before the baseline
  • Average of tacrorimus minimum blood concenration level is 3-10 ng/mL from transplanted date to baseline.
  • Female subjects who have child bearing potential must have a negative at urine or serum pregnancy test prior to enrollment and must agree to practice effective contraceptive measures during the study.(The oral contraceptive pill is not allowed to take a female subject)
  • Subjects who are clinically stable judged by investigator.
  • Subjects capable of understanding the purpose and risks of the study, having been fully informed and has given written informed consent to participate in the study

Who cannot join

  • Subjects previously received an organ transplantation excluding liver transplantation. Or Subjects received an auxiliary graft or bioartificial liver(cell system).
  • Recently there was acute rejection from the day of liver transplantation to baseline
  • If the onset of a new malignant cancer after liver transplantation is diagnosed, well treated basal cell carcinoma or squamous cell carcinoma is classified as an exception
  • When it is known that there is a hypersensitivity reaction to the ingredients of tacrolimus or the test drug
  • In the opinion of the investigator, there is an unstable medical condition that can affect the purpose of the clinical trial
  • In the event of material abuse, mental disorder or anything that can not smoothly communicate with the inverstigator in the opinion of the investigator
Show all 13Show fewer
  • Currently, if subjects are participating in other clinical trials or if subjects receive another drug for clinical trials within 28 days before baseline
  • If subjects have received a prohibited combination therapy currently or within 28 days before the baseline
  • Pregnant or lactating women
  • If known for HIV-positive
  • When there is a high possibility that subject will not be able to obey the visit schedule planned in protocol
  • Those who have clinically significant renal dysfunction judged by the investigator or at baseline serum creatinine level exceeds 1.6 mg / dL or GFR (MDRD) is less than 30 mL / min
  • Those who have clinically significant liver function disorder judged by the investigator or at the baseline, the values of SGPT / ALT and / or SGOT / AST and / or bilirubin are more than three times the upper limit of the laboratory normal range When raised

About this study

Official title: A Single Center, Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus Modified Release, ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients.

Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.

Read the detailed description

This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set * 100 Only those acute rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions.

Administration method is following The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).

  • Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ ml or below for 3 to 6 months of study treatment.
  • Duration of treatment The investigational product will be administered for 24 weeks.
Being tested
ADVAGRAF®
Keywords
ADVAGRAF®, Liver Transplantation, tacrolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADVAGRAF®Drug

    Also called tacrolimus

    Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).

    • Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment.
    • Duration of treatment The investigational product will be administered for 24 weeks.
Study groups in NCT03423225
Study groupRoleWhat they receive
ADVAGRAF®ExperimentalOne arm: Treatment conversion will take placefrom twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.
Receives: Drug: ADVAGRAF®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of acute rejection reaction confirmed by biopsy within 24 weeks after conversion

    Incidence rate of acute rejection reaction (%) = The number of subjects with at least one acute rejection reaction / Total number of subjects included in the analysis group * 100 number of subjects in the relevant analysis set * 100

    Measured: within 24 weeks

Secondary outcomes (4)

  1. Severity of acute rejection reaction confirmed by biopsy within 24 weeks after conversion

    Severity of acute rejection reactions is defined as the highest severity in a subject who had at least one acute rejection reaction.

    Measured: within 24 weeks

  2. Survival rates of subjects after conversion

    Measured: at week 24

  3. Survival rate of transplanted organs after conversion

    Measured: at week 24

  4. Blood concentration of tacrolimus

    Measured: at week -4, week 0, week 2, week 4, week 8, week 16 and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2018
  2. Study start22 Mar 2016
  3. Primary completion18 Jul 2017
  4. Study completion14 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03423225
Sponsor's protocol ID
Assign
Status last verified
Feb 2018
First submitted
22 Jan 2018
Last updated
6 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ADVAGRAF® in people with Liver Transplantation, run by Kim, Seoung-Hoon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of acute rejection reaction confirmed by biopsy within 24 weeks after conversion (time frame: within 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03423225.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.

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