Hepatitis; Virus, Chronic, Type BPhase 2NCT02966964
A Clinical Trials to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With HBV
A Phase 2 study testing DWPUR001 in people with Hepatitis; Virus, Chronic, Type B, run by Uijeongbu St. Mary Hospital at 6 sites in South Korea.
Trial summary
The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2 group or control group randomly. All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day for 48 weeks. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Hepatitis; Virus, Chronic, Type B
- What is being tested?
- DWPUR001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Apr 2015to Feb 2019
- Phase
- Phase 2
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at the age in between 19 and 69 years at the time of agreement
- Patients who had HBsAg-positive at least within 24 weeks or had a diagnosis with chronic hepatic disease by image test within 24 weeks from the time of screening.
- Patients who had HBeAg-positive and HBV DNA level≥20,000 IU/mL, or HBeAg-negative and HBV DNA level≥2,000 IU/mL
- Patients never treated with Tenofovir
- Patients whose ALT level is more than 2 times of UNL at the time of screening
- Patients prothrombin time prolonged≤4sec at the time of screening
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- Patients Total bilirubin level≤3.0mg/dL at the time of screening
- Patients albumin level≥3.0g/dL at the time of screening
- Patients ELF score≥8.5 at the time of screening
- Patients who agree with the clinical trial voluntarily and sign on the agreement
Who cannot join
- HIV, HCV or HDV infedted patients
- Patients who have abnormal liver function caused by other diseases (e.g. hematochromatosis, Wilson's disease, alcoholic hepatitis, Nonalcoholic steatohepatitis, alpha 1 antitrypsin deficiency)
- Patients who had suffered from variceal haemorrhage or hepatic encephalopathy
- Patients who need/had liver transplant
- Patients who have severe biliary obstruction, fulminant hepatic failure, radio-opacity gallstone, non-functional gall bladder, acute cholecystitis, Lactic acidosis/ adiposis
- Patients who have enteritis and colitis like peptic ulcer or Crohn's disease
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- Patients who have significant kidney disease, cardiovascular disease, lung disease, nervous disease, self-immune disease, bone disease (ex: osteomalacia, osteopenia, chronic osteomyelitis, osteopsathyrosis, osteochondrosis, multiple fracture) or malignant tumor.
- Patients who have systemic infection
- Patients who have hypersensitivity to ursodeoxycholic acid or Tenofovir
- Patients who have the generic problem as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Patients described as below at the time of screening
- Hb<8g/dL
- eGFR<60mL/min/1.73m2
- AFP level>200ng/mL or had a diagnosis with hepatocellular carcinoma based on the radiology result within 24 weeks
- Patients who had immune- or cytokine-based antiviral agents treatment (ex. Interferon α, Peginterferon α), or immunosuppression therapy (ex. Cyclosporine, Tacrolimus) in 24 weeks at the time of screening
- Patients who have to use the contraindication of comedication drugs during clinical trial or can't get the wash-out period
- Women of child-bearing potential not using an effective birth control method
- Patients who have psychiatric disorders or drug or alcohol abuse, so can't understand the purpose and process of this clinical trial
- Patients who participated in other clinical trial in 30 days prior to the enrollment in this study
- Patients who were determined inappropriate by the investigator to participate in this study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan-si
- Recruiting
Bundang CHA medical center
Bundang
- Recruiting
Incheon St. Mary Hospital
Incheon
- Recruiting
Severance Hospital
Seoul
- Recruiting
Ajou University Medical Center
Suwon
- Recruiting
Uijeongbu St. Mary Hospital
Uijongbu
About this study
Official title: An Exploratory, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With Hepatitis B Virus(HBV)
The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2 group or control group randomly.
All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo of DWPUR001 twice a day for 48 weeks.
- Conditions
- Hepatitis; Virus, Chronic, Type B
- Being tested
- DWPUR001, Placebo
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWPUR001Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir 300mg qd + DWPUR001 500mg bid | Experimental | Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months Receives: Drug: DWPUR001 |
| Tenofovir 300mg qd + DWPUR001 300mg bid | Experimental | Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months Receives: Drug: DWPUR001 |
| Tenofovir 300mg qd + DWPUR001 Placebo bid | Placebo comparator | Tenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of normalization of ALT level (≤1× ULN)(%)
Measured: At the 4 weeks
Secondary outcomes (5)
The proportion of normalization of ALT level (≤1× ULN)(%)
Measured: At the 2, 8, 12, 24, 36, 48 weeks
The change of fibrosis marker(ELF score) compared with the baseline
Measured: At the 48 weeks
The change of immunological marker(PD-1, CTLA-4, FoxP3) compared with baseline
Measured: At the 12, 24, 48 weeks
The change of anti-oxidant/anti-inflammatory marker(SOD, MDA, TNF-α)
Measured: At the 24, 48 weeks
The change of HBV DNA level compared with baseline (IU/mL)
Measured: At the 12, 24, 36, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startApr 2015
- Primary completionNov 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis; Virus, Chronic, Type BStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uijeongbu St. Mary Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Chang Wook Kim, Uijeongbu St. Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966964
- Sponsor's protocol ID
- EURECA001
- Status last verified
- Sep 2017
- First submitted
- 15 Nov 2016
- Last updated
- 25 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With Hepatitis B Virus(HBV)
- ClinicalTrials.gov ID
- NCT02966964
- Acronym / sponsor ID
- EURECA001
- Conditions
- Hepatitis; Virus, Chronic, Type B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Uijeongbu St. Mary HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- Apr 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- 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.
The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2 group or control group randomly.
All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo of DWPUR001 twice a day for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tenofovir 300mg qd + DWPUR001 500mg bid | Experimental | Drug: DWPUR001Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months |
| Tenofovir 300mg qd + DWPUR001 300mg bid | Experimental | Drug: DWPUR001Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months |
| Tenofovir 300mg qd + DWPUR001 Placebo bid | Placebo comparator | Drug: PlaceboTenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients at the age in between 19 and 69 years at the time of agreement
- Patients who had HBsAg-positive at least within 24 weeks or had a diagnosis with chronic hepatic disease by image test within 24 weeks from the time of screening.
- Patients who had HBeAg-positive and HBV DNA level≥20,000 IU/mL, or HBeAg-negative and HBV DNA level≥2,000 IU/mL
- Patients never treated with Tenofovir
- Patients whose ALT level is more than 2 times of UNL at the time of screening
Key exclusion criteria (20 listed)
- HIV, HCV or HDV infedted patients
- Patients who have abnormal liver function caused by other diseases (e.g. hematochromatosis, Wilson's disease, alcoholic hepatitis, Nonalcoholic steatohepatitis, alpha 1 antitrypsin deficiency)
- Patients who had suffered from variceal haemorrhage or hepatic encephalopathy
- Patients who need/had liver transplant
- Patients who have severe biliary obstruction, fulminant hepatic failure, radio-opacity gallstone, non-functional gall bladder, acute cholecystitis, Lactic acidosis/ adiposis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWPUR001 | Drug | Tenofovir 300mg qd + DWPUR001 300mg bid, Tenofovir 300mg qd + DWPUR001 500mg bid |
| Placebo | Drug | Tenofovir 300mg qd + DWPUR001 Placebo bid |
Primary outcome
The proportion of normalization of ALT level (≤1× ULN)(%)
Time frame: At the 4 weeks
5 secondary outcomes
The proportion of normalization of ALT level (≤1× ULN)(%)
Time frame: At the 2, 8, 12, 24, 36, 48 weeks
The change of fibrosis marker(ELF score) compared with the baseline
Time frame: At the 48 weeks
The change of immunological marker(PD-1, CTLA-4, FoxP3) compared with baseline
Time frame: At the 12, 24, 48 weeks
The change of anti-oxidant/anti-inflammatory marker(SOD, MDA, TNF-α)
Time frame: At the 24, 48 weeks
The change of HBV DNA level compared with baseline (IU/mL)
Time frame: At the 12, 24, 36, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DWPUR001 in people with Hepatitis; Virus, Chronic, Type B, run by Uijeongbu St. Mary Hospital at 6 sites 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 10 inclusion and 20 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chang Wook Kim, M.D., Ph.D. (+82-31-847-2719, cwkim@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of normalization of ALT level (≤1× ULN)(%) (time frame: At the 4 weeks). 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 25 Sep 2017.