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

NCT05282407 | Completed Phase 4

• 1 other identifier: TNLD01
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (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)

  48 weeks

Secondary Outcomes (10)

• Inhibiting† rate of HBV virus at 12, 24 and 36 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)

  12, 24, and 36 weeks

• Undetected‡ rate of HBV virus at 12, 24, 36 and 48 weeks after baseline ‡ The lower limit of quantification (LLOQ) for each institution is used, and if it is less than the LLOQ, the HBV DNA level is set to '0'.

  12, 24, 36 and 48 weeks

• Change of HBV DNA(log10 copies/mL) at 12, 24, 36 and 48 weeks from baseline

  12, 24, 36 and 48 weeks

• Loss rate of HBeAg in HBeAg(+) patients at 12, 24, 36 and 48 weeks after baseline

  12, 24, 36 and 48 weeks

• Seroconversion† rate of HBeAg in HBeAg(+) patients at 12, 24, 36 and 48 weeks after baseline †Generation of anti-HBe

  12, 24, 36 and 48 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Tenolid Tab

Drug: Tenofovir disoproxil 245mg

Control group

ACTIVE COMPARATOR

Viread Tab

Drug: Tenofovir disoproxil fumarate 300mg

Interventions

Tenofovir disoproxil 245mg DRUG

1 tablet q.d. for 48 weeks

Experimental group

Tenofovir disoproxil fumarate 300mg DRUG

1 tablet q.d. for 48 weeks

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samjin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yoon Jun Kim, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 16, 2022
• Study Start: November 20, 2017
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: April 1, 2022

Record last verified: 2022-02

Locations

KR (1)