Status:
COMPLETED
Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Patients With Chronic Hepatitis B
Lead Sponsor:
Samjin Pharmaceutical Co., Ltd.
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief 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 continuou...
Eligibility Criteria
Inclusion
- 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.
- † 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)
- Subject who voluntarily consents to participate in the clinical trial and signs an informed consent
Exclusion
- 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)
- 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
- 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
- Patients who administered immunosuppressive drugs within 24 weeks prior to screening or who administered systemic corticosteroids over a limited dose (equivalent to prednisolone 10 mg/day) for 4 consecutive weeks or more.
- Patients who are expected to require administration of the following drugs during the clinical trial period
- ① Immunosuppressive drug
- ② Systemic corticosteroids above a limited dose (equivalent to prednisolone 10 mg/day) for 2 consecutive weeks or more
- ③ Drugs affecting renal excretion, drugs inducing nephrotoxicity or hepatotoxicity
- ④ Anti-HBV drugs other than Tenofovir (ex. emtricitabine, lamivudine, telbivudine, clevudine, entecavir, interferone)
- ⑤ Patients who administered hepatotonics at a stable dose for more than 3 months before screening can be registered.
- Those who have a history of fractures requiring bone mineral density (BMD) monitoring or are at risk of osteopenia, who are judged unable to participate in clinical trials according to the investigator's judgment
- For pregnant, lactating and reproductive women, patients who do not consent to contraception by a medically accepted method (surgical sterilization, intrauterine device, condom or diaphragm) during the clinical trial period
- Patients who participated in another clinical trial within 12 weeks prior to screening and received investigational drugs or investigational devices.
- In addition to the above, subject considered ineligible to participate in this study by the investigator.
Key Trial Info
Start Date :
October 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2020
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT05286346
Start Date
October 12 2018
End Date
August 10 2020
Last Update
May 16 2025
Active Locations (1)
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1
Dong-A University Hospital
Busan, South Korea