NCT02805738

Brief Summary

A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

20 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

June 21, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

June 16, 2016

Last Update Submit

June 19, 2016

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis BtenofovirCKD-390

Outcome Measures

Primary Outcomes (1)

  • The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)

    24weeks after drug administration

Secondary Outcomes (8)

  • The rate of subjects who showed HBV DNA undetected (less than 20IU/mL)

    12, 36, 48 weeks after drug administration

  • The Difference between the baseline and at the 12, 24, 36, 48 week of HBV DNA level

    12, 24, 36, 48 weeks after drug administration

  • The rate of subjects who had normal ALT result

    12, 24, 36, 48weeks after drug administration

  • The rate of subjects who showed HBeAg loss

    24, 48 weeks after drug administration

  • The rate of subjects who showed HBeAg seroconversion

    24, 48 weeks after drug administration

  • +3 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

once a time per a day, CKD-390 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks

Drug: CKD-390

Active comparator Group

ACTIVE COMPARATOR

once a time per a day, Viread 1 Tablet for each other, PO, During 24 weeks, once a time per a day, 1 tab(CKD-390 1 Tablet) for each other, PO, From 24 weeks to 48 weeks

Drug: viread

Interventions

CKD-390DRUG

CKD-390 1 Tablet (48 weeks)

Also known as: Tenofovir disoproxil aspartate 308.04mg
Experimental Group
vireadDRUG

viread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks)

Also known as: Tenofovir disoproxil fumarate 300mg
Active comparator Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female older than 19 years at the time of screening
  • Patients who have chronic hepatitis B disease are taken Viried for 6 months
  • Patients who show HBV DNA undetected(less than 20 IU/mL)
  • Patients who show positive HBsAg
  • Patients who show positive HBeAg or negative HBeAg
  • Patients who fully understand the clinical trials after in-depth explanation, decided to join the clinical trials by their will and signed inform consent

You may not qualify if:

  • Patients who are not taken any anti-viral agents except Viread Tab
  • Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
  • Patients who have seroperitoneum, icterus, hepatic encephalopathy, variceal hemorrhage or Patients with following value at screening
  • total bilirubin \> Upper normal limit x 1.5
  • prothrombin time(INR) \> Upper normal limit x 1.5
  • platelets \< 75,000/ul
  • serum albumin \< 3.0g/dl
  • Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 50ng/mL
  • Patients who show Creatinine Clearance \< 50 mL/min by calculating Cockcroft-Gault equation
  • Patients with disease like heart failure, renal failure, pancreatitis that investigators consider ineligible for this study
  • Patients who have other hepatic diseases like hematochromatosis, Wilson's disease, alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome
  • Patients with genetic disease like Galactose intolerance, lapplactase deficiency, Glucose-galactose malabsorption
  • History of malignant tumor within 5 years
  • Patients who take any other investigational product within 30 days
  • Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, South Korea

NOT YET RECRUITING

Bundang Cha Medical Center

Bundang, Gyeonggi-do, South Korea

NOT YET RECRUITING

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, Gyeonggi-do, South Korea

RECRUITING

Gachon University of Medicine and Science Gil Medical Center

Incheon, Gyeonggi-do, South Korea

ACTIVE NOT RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

ACTIVE NOT RECRUITING

Busan National University Hospital

Busan, South Korea

ACTIVE NOT RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

ACTIVE NOT RECRUITING

Yeungnam University Medical Center

Daegu, South Korea

NOT YET RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

NOT YET RECRUITING

Jeju National University Hospital

Jeju City, South Korea

NOT YET RECRUITING

Chungang University Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Hanyang University Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Kangnam Severance Hospital

Seoul, South Korea

NOT YET RECRUITING

Korea University Guro Hosptial

Seoul, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

ACTIVE NOT RECRUITING

Seoul Asan Medical Center

Seoul, South Korea

ACTIVE NOT RECRUITING

Seoul National University Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Seoul Saint Mary's Hospital

Seoul, South Korea

ACTIVE NOT RECRUITING

Severance Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kwan Sik lee, MD

    Kangnam severance hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 20, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2017

Study Completion

March 1, 2018

Last Updated

June 21, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(20)