Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02967939
Other study ID # DA2802_HB_III
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 28, 2017
Est. completion date July 15, 2019

Study information

Verified date April 2021
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients


Description:

1. DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks. 2. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date July 15, 2019
Est. primary completion date January 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with chronic hepatitis B aged 18 years or older - Subjects who have evidence to demonstrate a history of chronic hepatitis B for at least six months from the time of screening visit - Subjects who have HBsAg positive test at screening visit - Subjects who did not receive the hepatitis B treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test - Subjects with an ALT of 80 units or more and 10 times lower than the normal upper limit at the time of screening Exclusion Criteria: - Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus - Subjects with creatinine clearance of less than 50 ml/min at the screening visit - At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma - Subjects with decompensated liver disease who meet the following criteria: 1. Total bilirubin levels greater than 2.5 mg/dl 2. Prothrombin time is at least 3 seconds longer than normal upper limit 3. Serum albumin value less than 30 g/l 4. Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DA-2802
DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
Viread®
Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.

Locations

Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference of HBV DNA level(log10) Change from baseline at 48 weeks
Secondary Percentage of subjects HBV DNA < 400 copies/ml at 24 weeks, 48 weeks
Secondary Percentage of subjects who had normal ALT levels at 24 week, 48 week
Secondary Percentage of subjects who experienced loss of HBeAg at 24 week, 48 week
See also
  Status Clinical Trial Phase
Completed NCT03272009 - Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects Phase 1
Recruiting NCT01456312 - HBsAg Related Response Guided Therapy Phase 4
Terminated NCT01886300 - An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam N/A
Completed NCT01023230 - A Study to Assess DV-601 in Subjects With Chronic Hepatitis B Phase 1
Completed NCT00962975 - A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies Phase 1
Completed NCT00536263 - PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327) Phase 3
Terminated NCT00460850 - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B. Phase 4
Completed NCT03681132 - The Norwegian Nucleoside Analogue Stop Study Phase 4
Active, not recruiting NCT05473806 - Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes Phase 4
Withdrawn NCT01179594 - A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B. Phase 4
Recruiting NCT05057065 - A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
Completed NCT04439539 - A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection Phase 2
Withdrawn NCT03125213 - A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects Phase 2
Active, not recruiting NCT04782375 - Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B Phase 4
Withdrawn NCT05550519 - A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment Early Phase 1
Completed NCT02693652 - A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine Phase 1/Phase 2
Enrolling by invitation NCT04160897 - Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
Active, not recruiting NCT02588937 - Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients Phase 4
Completed NCT02612506 - Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers Phase 1
Recruiting NCT02327416 - A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study) Phase 3