Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Teno… (NCT05286346) | Clinical Trial Compass
CompletedPhase 4
Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B
South Korea113 participantsStarted 2018-10-12
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. As of the date of written consent, adults aged 19 or above
✓. Patients with chronic hepatitis B
✓. 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.
✓. Subject who voluntarily consents to participate in the clinical trial and signs an informed consent
Exclusion criteria
✕. Patients with liver cancer or decompensated liver cirrhosis\* \*Cirrhosis with clinical signs/symptoms of decompensation (jaundice, ascites, variceal bleeding, hepatic coma)
✕. 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.
✕. Patients with other clinically significant liver disease (Hemochromatosis, Wilson's disease, Alcoholic liver disease, Autoimmune hepatitis, α-1 antitrypsin deficiency)
What they're measuring
1
Inhibiting†rate of HBV virus at 48 weeks after baseline †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)
✕. Patients confirmed by laboratory test results as followings
✕. 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),.
✕. Patients who are scheduled for an organ transplantation or who have undergone organ transplantation surgery
✕. Patients with a history of clinically significant neuropsychiatric disorders, alcoholism, or drug dependence
✕. Patients known to have hypersensitivity or allergy to components of investigational products or similar drugs