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HEPATITISPhase 4OPTIMUS-ANCT02075242

TO Compare the Triple Drug Therapy and Dual Therapy .

A Phase 4 study testing Mycophenolate Mofetil and Tacrolimus in people with HEPATITIS, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study to Compare the Safety and Efficacy of Tacrolimus and Steroids in Combination With Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation with Hepatitis B Virus(HBsAg) Positive Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
HEPATITIS
What is being tested?
Mycophenolate Mofetil and Tacrolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteSouth Korea
Study dates
Jan 2014to Jan 2016
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women at the age of 20 to 65
  • Patients who will have primary Liver Transplantation becaused of Chronic Hepatitis B of HbsAg positive
  • Having confirmed a result of HBsAg positive patients within 6 months prior to Screening point.
  • Patients who will have Liver Transplantation from ABO-compatible or proper living donor ⑤ Patients who will receive investigational products for the entire period of clinical trial.
  • Patients who have signed the informed consent after understanding of clinical trial's purpose and risk.
  • For women of childbearing potential, pregnancy test negative from urine or blood AND women who agree to contraception for the entire period of clinical trial.

Who cannot join

  • Recipients who had Liver Transplantation OR who had or will have other organ transplantation
  • Recipients who other organ transplantation in addition to liver at once.
  • Recipients who will have Auxiliary Partial Orthotopic Liver Transplantation.
  • Recipients who use a Bioartificial liver prior to Transplantation
  • Cr > 2.0mg/dl at screening test
  • Patients who had malignant tumor within the past 5 years OR have malignant tumor(except, successfully treated Skin's non-metastatic basal cell carcinoma, squamous cell carcinoma or primary hepatocellular carcinoma )
Show all 15Show fewer
  • Recipients had hepatocellular carcinoma whick is out of Milan criteria
  • WBC<1,500/mm3 or ANC<900/mm3 or PLT<30,000/mm3 at Screening
  • Investigator judge that a patient is not proper to enroll this study due to Severe digestive disorder at Screening
  • Patients who have severe systemic infection (But the liver transplantation is excepted that performed after the infection is completely lost or well-controlled)
  • ⑪ Recipients who had Liver transplantation from HBsAg positive donor
  • ⑫ Recipients or Donors are HIV, HCV Positive
  • ⑬ Patients who need to systemc chemotherapy or immunosuppressive therapy prior to transplantation or took immunosuppressants within 30 days prior to liver transplantation(except, investigational products per protocol and corticosteroid)
  • ⑭ Patients who have hypersensitivity to mycophenolate, mycophenolate acid, ingredient of investigational products, tacrolimus , Macrolide antibiotic and Steroids
  • ⑮ Patients who had been received or have been received other investigational products within 28 days prior to screening 16 Pregnant women and lactating women 17 Substance abuse patient, mentally defective person or patients who is not possible to participate in clinical trial by law 18 Investigator judge that a patient have communication disorder 19 Patients are not capable of visiting accor.ding to study visit schedule 20 Investigator judge that a patient is not proper to enroll this study, et cetera

Trial locations and contacts

1 site in 1 country.

yun-kyoung kim contact

82-31-219-4467

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, Korea

    Sung-Gyu Lee, sglee2@amc.seoul.kr

    Sung-Gyu Lee

    Recruiting

Other trials in South Korea

About this study

Official title: Open Label, Multi-center, Randomized Study to Compare of Tacrolimus and Steroids in Combination With Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation With Hepatitis B Virus(HBsAg) Positive

Study to Compare the Safety and Efficacy of Tacrolimus and Steroids in Combination With Mycophenolate Mofetil or Without Mycophenolate Mofetil in Liver Transplantation with Hepatitis B Virus(HBsAg) Positive

Conditions
HEPATITIS
Keywords
HBV
Medical subject headings
Hepatitis

What participants receive

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

  • Mycophenolate MofetilDrug

    Also called Tacrolimus + Mycophenolate Mofetil+Corticosteroid

    experimental group receive Tacrolimus as a main immunosuppressants and assistant is My-rept capsule®(Mycophenolate Mofetil),

  • TacrolimusDrug

    Also called Tacrolimus + Corticosteroid

    control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product

Study groups in NCT02075242
Study groupRoleWhat they receive
tacrolimusActive comparatorControl group: Tacrolimus + Corticosteroid (dual oral therapy)
Receives: Drug: Tacrolimus
Mycophenolate MofetilExperimentalTacrolimus + Mycophenolate Mofetil+Corticosteroid (triple oral therapy)
Receives: Drug: Mycophenolate Mofetil; Drug: Tacrolimus

What is being measured

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

  1. rejection

    • Incidence rate has been confirmed acute cellular rejection(RAI 4 and over) from liver biopsy

    Measured: within 6months

Secondary outcomes (2)

  1. rate of HBV

    • Recurrence rate of HBV after liver transplantation for 24 weeks (HBsAg Positve)

    Measured: within 6 months

  2. Graft survival rate

    • Patients survival rate after liver transplantation for 24 weeks / Graft survival rate

    Measured: within 6 months

Timeline

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

  1. First posted3 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2016 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02075242
Sponsor's protocol ID
2011-0900
Other IDs
2011-0900
Acronym
OPTIMUS-A
Status last verified
Feb 2014
First submitted
26 Feb 2014
Last updated
3 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mycophenolate Mofetil and Tacrolimus in people with HEPATITIS, run by Asan Medical Center at 1 site in South Korea.

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 15 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: status not confirmed, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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

Contact yun-kyoung kim (82-31-219-4467), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rejection (time frame: within 6months). 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 NCT02075242.

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 3 Mar 2014.

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