A Clinical Trials to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With HBV

Phase 2

• Conditions: Hepatitis; Virus, Chronic, Type B
• Interventions: Drug: DWPUR001; Drug: Placebo

• Registration Number: NCT02966964
• Lead Sponsor: Uijeongbu St. Mary Hospital

Brief 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. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo of DWPUR001 twice a day for 48 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-17
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25
• Primary Completion: 2018-11
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients at the age in between 19 and 69 years at the time of agreement
2. 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.
3. Patients who had HBeAg-positive and HBV DNA level≥20,000 IU/mL, or HBeAg-negative and HBV DNA level≥2,000 IU/mL
4. Patients never treated with Tenofovir
5. Patients whose ALT level is more than 2 times of UNL at the time of screening
6. Patients prothrombin time prolonged≤4sec at the time of screening
7. Patients Total bilirubin level≤3.0mg/dL at the time of screening
8. Patients albumin level≥3.0g/dL at the time of screening
9. Patients ELF score≥8.5 at the time of screening
10. Patients who agree with the clinical trial voluntarily and sign on the agreement

Exclusion Criteria

1. HIV, HCV or HDV infedted patients

2. Patients who have abnormal liver function caused by other diseases (e.g. hematochromatosis, Wilson's disease, alcoholic hepatitis, Nonalcoholic steatohepatitis, alpha 1 antitrypsin deficiency)

3. Patients who had suffered from variceal haemorrhage or hepatic encephalopathy

4. Patients who need/had liver transplant

5. Patients who have severe biliary obstruction, fulminant hepatic failure, radio-opacity gallstone, non-functional gall bladder, acute cholecystitis, Lactic acidosis/ adiposis

6. Patients who have enteritis and colitis like peptic ulcer or Crohn's disease

7. 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.

8. Patients who have systemic infection

9. Patients who have hypersensitivity to ursodeoxycholic acid or Tenofovir

10. Patients who have the generic problem as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

11. 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

12. 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

13. Patients who have to use the contraindication of comedication drugs during clinical trial or can't get the wash-out period

14. Women of child-bearing potential not using an effective birth control method

15. Patients who have psychiatric disorders or drug or alcohol abuse, so can't understand the purpose and process of this clinical trial

16. Patients who participated in other clinical trial in 30 days prior to the enrollment in this study

17. Patients who were determined inappropriate by the investigator to participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir 300mg qd + DWPUR001 500mg bid	DWPUR001	Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months
Tenofovir 300mg qd + DWPUR001 300mg bid	DWPUR001	Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months
Tenofovir 300mg qd + DWPUR001 Placebo bid	Placebo	Tenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months

Primary Outcome Measures

Name	Time	Method
The proportion of normalization of ALT level (≤1× ULN)(%)	At the 4 weeks

Secondary Outcome Measures

Name	Time	Method
The proportion of normalization of ALT level (≤1× ULN)(%)	At the 2, 8, 12, 24, 36, 48 weeks
The change of fibrosis marker(ELF score) compared with the baseline	At the 48 weeks
The change of immunological marker(PD-1, CTLA-4, FoxP3) compared with baseline	At the 12, 24, 48 weeks
The change of anti-oxidant/anti-inflammatory marker(SOD, MDA, TNF-α)	At the 24, 48 weeks
The change of HBV DNA level compared with baseline (IU/mL)	At the 12, 24, 36, 48 weeks

Trial Locations

Locations (6)

Korea University Ansan Hospital; 🇰🇷 Ansan-si, Korea, Republic of

Bundang CHA medical center; 🇰🇷 Bundang, Korea, Republic of

Incheon St. Mary Hospital; 🇰🇷 Incheon, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Ajou University Medical Center; 🇰🇷 Suwon-si, Korea, Republic of

Uijeongbu St. Mary Hospital; 🇰🇷 Uijongbu, Korea, Republic of