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COMPLETEDPHASE4

A phase4 Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B

A Multi-Center, Randomized, Open-label, Parallel, Active-controlled, Non-inferiority, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Switching to Tenolid Tab From Viread Tab in Chronic Hepatitis B Patients on Treatment With Tenofovir Disoproxil Fumarate

NCT05282407•Samjin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase4, multicenter, open-label, randomized study to demonstrate that the Tenolid Tab switching group is non-inferior to the virologic suppression effect compared to the Viread Tab continuous administration group and evaluate the safety of Tenolid Tab. This clinical trial was conducted on patients who were taking Viread Tab as monotherapy for more than 48 weeks for chronic hepatitis B. At the time of screening(Visit 1), information on factors related to medical history and prognosis including Viread Tab administration were collected retrospectively from the subjects who voluntarily signed the informed consent form (ICF). Only subjects who are determined to be suitable for the study eligibility(inclusion/exclusion) criteria as a result of the screening evaluations are randomized in a 1:1 ratio to one of the two groups at the baseline. Subjects will receive investigational product start on the next day of randomization for 48 weeks. Subjects will visit to the study site on 12, 24, 36, 24 weeks after starting dosing investigational product and evaluated for effectiveness of virologic suppression and safety.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. As of the date of written consent, adults aged 19 or above
•2. Patients with chronic hepatitis B
•3. For chronic hepatitis B, Viread Tab. monotherapy† for more than 48 weeks, HBV suppression‡(virologic suppression) was confirmed, and it was determined that Tenofovir monotherapy for more than 48 weeks would be required.
•† However, patients who take Viread Tab for more than 48 weeks before screening but do not take Viread Tab at the time of screening and discontinue the administration within 4 weeks until the time of randomization can be registered. (treatment gap ≤ 28 days)
•* HBV DNA \< 400 copies/mL (=69 IU/mL\*) \* IU/mL is converting to copies/mL by unit for each institution. (Ex: 5.8 copies/mL = 1 IU/mL)
•4. Subject who voluntarily consents to participate in the clinical trial and signs an informed consent

Exclusion Criteria

•1. Patients with liver cancer or decompensated liver cirrhosis\* \*Cirrhosis with clinical signs/symptoms of decompensation (jaundice, ascites, variceal bleeding, hepatic coma)
•2. Patients with Hepatitis C virus (HCV), human immunodeficiency virus (HIV) with overlapping infections (HCV Ab positive, HIV Ab positive) However, if the HCV Ab or HIV Ab test result is judged to be 'false positive' by the investigator, HCV or HIV infection can be confirmed through additional confirmatory tests (HCV, HIV RNA test), etc.
•3. Patients with other clinically significant liver disease (Hemochromatosis, Wilson's disease, Alcoholic liver disease, Autoimmune hepatitis, α-1 antitrypsin deficiency)
•4. Patients confirmed by laboratory test results as followings
•* Severe anemia: Hemoglobin \< 8g/dL ② Inadequate renal function: eGFR (Ccr, Cockcroft-Gault formula) \< 50 mL/min ③ Inadequate hepatic function:
•* Total bilirubin \> 3.0 mg/dL
•* Albumin \< 2.8 mg/dL
•* Prothrombin Time(PT) \> INR 2.2
•5. Patients with malignant tumors diagnosed within 5 years prior to screening However, in the case of basal cell carcinoma or squamouscell carcinoma of the skin, it is possible to participate in the clinical trial if it is judged to be 'cured' at the discretion of the investigator after surgery (treatment),.
•6. Patients who are scheduled for an organ transplantation or who have undergone organ transplantation surgery
+13 more criteria

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

November 20, 2017

Primary Completion Date

April 17, 2019

Completion Date

April 17, 2019

Last Updated

April 1, 2022

Enrollment

118

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

Tenofovir disoproxil 245mg

DRUG

Tenofovir disoproxil fumarate 300mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A phase4 Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

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