Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-03-31

Brief Summary

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

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Detailed Description

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A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 tablet and Viread® tablet in Chronic hepatitis B Patients Subjects will receive either a single oral dose of the test formulation(CKD-390) or a oral dose of the reference formulation(viread).

Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

CKD-390

Intervention Type DRUG

CKD-390 1 Tablet (48 weeks)

Active comparator Group

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

Group Type ACTIVE_COMPARATOR

viread

Intervention Type DRUG

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

Interventions

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CKD-390

CKD-390 1 Tablet (48 weeks)

Intervention Type DRUG

viread

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

Intervention Type DRUG

Other Intervention Names

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Tenofovir disoproxil aspartate 308.04mg Tenofovir disoproxil fumarate 300mg

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients who are not taken any anti-viral agents except Viread Tab
2. Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
3. 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
4. Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 50ng/mL
5. Patients who show Creatinine Clearance \< 50 mL/min by calculating Cockcroft-Gault equation
6. Patients with disease like heart failure, renal failure, pancreatitis that investigators consider ineligible for this study
7. Patients who have other hepatic diseases like hematochromatosis, Wilson's disease, alcoholic cirrhosis, autoimmune hepatic diseases, α-1 antitrypsin deficit syndrome
8. Patients with genetic disease like Galactose intolerance, lapplactase deficiency, Glucose-galactose malabsorption
9. History of malignant tumor within 5 years
10. Patients who take any other investigational product within 30 days
11. Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
12. Pregnant, breast-feeding and childbearing age who don't use adequate contraception
13. Patients who receive an organ transplant or bone marrow transplant or are going to received surgury
14. History of allergic reaction to the investigational product
15. Patients that investigators consider ineligible for this study

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No