Chronic Hepatitis b With Multidrug ResistanceNCT03597633
Tenofovir Combination or Mono-therapy for MDR CHB
An observational study of Chronic Hepatitis b With Multidrug Resistance, run by Korea University at 1 site in South Korea.
Trial summary
Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Hepatitis b With Multidrug Resistance
- How many people
- 236 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2013to 31 Dec 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: Chronic hepatitis B patients with multiple drug resistance.
Who may be able to join
- CHB patients with:
- documented HBsAg positivity at least 6 months before enrollment
- age >18 years old,
- confirmed genotypic resistance to more than two classes of NAs
- HBV DNA level ≥ 200 IU/mL
- compensated liver diseases (defined by Child-Pugh-Turcotte score <7; prothrombin time <3 seconds above upper limit of normal or international normalized ratio <1.5; serum albumin >3 g/dL; total bilirubin <2.5 mg/dL; no history of esophago-gastric variceal bleeding, ascites, over hepatic encephalopathy)
- willingness to give an informed consent.
Who cannot join
- laboratory abnormalities of low serum phosphorous level <2.0 mEq/dL, elevated serum creatinine >1.5 mg/dL, decreased creatinine clearance rate <50 mL/min, absolute neutrophil count <1000 cell/mL, or low hemoglobin level <10 g/dL (if female, <9 g/dL)
- no definite evidence of genotypic resistance
- positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus
- HCC
- a proof of pregnant or lactating women
- evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women)
- any untreated malignancy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
About this study
Official title: Tenofovir-based Combination Therapy or Monotherapy for Multi-drug Resistant Chronic Hepatitis B; Real World Data From Multicenter Cohort Study
Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.
Read the detailed description
Inclusion criteria were CHB patients with resistance to more than two classes of nucleos(t)ide analogues (NA) and hepatitis B virus (HBV) DNA level ≥200 IU/mL.
Patients will receive either TDF-base combination therapy or TDF monotherapy. The primary end point is virologic response (VR) defined by an undetectable HBV DNA (<20 IU/mL) at month 36.
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic Response
undetectable HBV DNA (<20 IU/mL)
Measured: 36 months
Secondary outcomes (6)
Virologic Response
undetectable HBV DNA (<20 IU/mL)
Measured: 60 months
mean HBV DNA
mean HBV DNA levels
Measured: 36 months, 60 months
ALT normalization
rates of ALT normalization
Measured: 36 months, 60 months
Hepatitis B e antigen (HBeAg) seroconversion
rates of Hepatitis B e antigen (HBeAg) seroconversion
Measured: 36 months, 60 months
virologic breakthrough
Incidence of virologic breakthrough defined by increase of HBV DNA more than 1 log IU/mL from nar dir.
Measured: 36 months, 60 months
Genotypic resistance
Detection of previously known mutations to be resistant to the drugs being administered.
Measured: 36 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Jun 2013
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis b With Multidrug ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Collaborators
- Yonsei University, CHA University, Soon Chun Hyang University, Chonbuk National University, Hallym University, Inje University, The Catholic University of Korea
- Responsible party
- Principal investigator, Hyung Joon Yim, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597633
- Sponsor's protocol ID
- MDRCHB
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenofovir-based Combination Therapy or Monotherapy for Multi-drug Resistant Chronic Hepatitis B; Real World Data From Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT03597633
- Acronym / sponsor ID
- MDRCHB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Collaborators
- Yonsei University, CHA University, Soon Chun Hyang University, Chonbuk National University, Hallym University, Inje University, The Catholic University of Korea
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.
Detailed description
Inclusion criteria were CHB patients with resistance to more than two classes of nucleos(t)ide analogues (NA) and hepatitis B virus (HBV) DNA level ≥200 IU/mL.
Patients will receive either TDF-base combination therapy or TDF monotherapy. The primary end point is virologic response (VR) defined by an undetectable HBV DNA (<20 IU/mL) at month 36.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis B patients with multiple drug resistance.
Key inclusion criteria (7 listed)
- CHB patients with:
Key exclusion criteria (7 listed)
- laboratory abnormalities of low serum phosphorous level <2.0 mEq/dL, elevated serum creatinine >1.5 mg/dL, decreased creatinine clearance rate <50 mL/min, absolute neutrophil count <1000 cell/mL, or low hemoglobin level <10 g/dL (if female, <9 g/dL)
- no definite evidence of genotypic resistance
- positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus
- HCC
- a proof of pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Virologic Response
Time frame: 36 months
undetectable HBV DNA (<20 IU/mL)
6 secondary outcomes
Virologic Response
Time frame: 60 months
mean HBV DNA
Time frame: 36 months, 60 months
ALT normalization
Time frame: 36 months, 60 months
Hepatitis B e antigen (HBeAg) seroconversion
Time frame: 36 months, 60 months
virologic breakthrough
Time frame: 36 months, 60 months
Genotypic resistance
Time frame: 36 months, 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No. Confidential
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis b With Multidrug Resistance, run by Korea University 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 7 inclusion and 7 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 24 Jul 2018. 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.
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?
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?
Virologic Response (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2018.