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

NCT02966964 | Unknown Phase 2

• 1 other identifier: EURECA001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

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.

Conditions

Hepatitis; Virus, Chronic, Type B

Outcome Measures

Primary Outcomes (1)

• The proportion of normalization of ALT level (≤1× ULN)(%)

  At the 4 weeks

Secondary Outcomes (5)

• 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

Study Arms (3)

Tenofovir 300mg qd + DWPUR001 500mg bid

EXPERIMENTAL

Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months

Drug: DWPUR001

Tenofovir 300mg qd + DWPUR001 300mg bid

EXPERIMENTAL

Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months

Drug: DWPUR001

Tenofovir 300mg qd + DWPUR001 Placebo bid

PLACEBO COMPARATOR

Tenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months

Drug: Placebo

Interventions

DWPUR001 DRUG

Tenofovir 300mg qd + DWPUR001 300mg bid; Tenofovir 300mg qd + DWPUR001 500mg bid

Placebo DRUG

Tenofovir 300mg qd + DWPUR001 Placebo bid

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Uijeongbu St. Mary Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (6)

Korea University Ansan Hospital

Ansan-si, South Korea

RECRUITING

Bundang CHA medical center

Bundang, South Korea

RECRUITING

Incheon St. Mary Hospital

Incheon, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

Ajou University Medical Center

Suwon, South Korea

RECRUITING

Uijeongbu St. Mary Hospital

Uijongbu, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chang Wook Kim, M.D., Ph.D.

CONTACT

+82-31-847-2719; cwkim@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: April 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

KR (6)