Treatment Efficacy and Safety of TDF-TAF Switch Study in South Korea

NCT ID: NCT03559790

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-18
• Study Completion Date: 2021-08-31

Brief Summary

Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc.

However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B.

The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.

Conditions

Chronic Hepatitis b

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

tenofovir alafenamide

To evaluate of efficacy and safety in patients with TDF-TAF switch therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

2. Adult male and non-pregnant, non-lactating female subjects, 18 years of age and older, based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopausal).

3. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months)

4. Previous TDF naïve treatment (more than 96 weeks) baseline status including chronic hepatitis B with the following:

• HBeAg-positive and HBeAb negative at Screening
• Screening HBV DNA ≥ 1x 105 copies/mL
• Screening serum ALT level ≥2×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
• HBeAg-negative and HBeAb positive at Screening
• Screening HBV DNA ≥ 1x 104 copies/mL
• Screening serum ALT level ≥2×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
• Cirrhosis at Screening
• Screening HBV DNA ≥ 1x 104 copies/mL regardless of HBeAg status

• Treatment naïve subjects defined as no history of antiviral therapy or < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue, including lamivudine or adefovir, clevudine, telbivudine, entecavir

5. The decision is made by the provider and patient to switch from TDF to TAF prior to discussion of the study of enrollment

6. Following the decision to switch therapy, signed written informed consent after being instructed about the objective and procedure of the clinical study

7. Must be willing and able to comply with all study requirements

Exclusion Criteria

1. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.

2. Co-infection with HCV, HIV

3. Evidence of hepatocellular carcinoma (e.g. α-fetoprotein> 50 ng/mL or as evidenced by recent ultrasound or other standard of care measure)

4. Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible

5. Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance

6. Currently receiving therapy with cytotoxic agent, nephrotoxic agents, or agents capable of modifying renal excretion

7. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Myeong Jun Song

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myeong Jun Song

Role: PRINCIPAL_INVESTIGATOR

Daejeon St. Mary's hospital

Locations

The Catholic University of Korea, Daejeon St.Mary's Hosptial

Junggu, Daejeon, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Myeong Jun Song, Ph D

Role: CONTACT

mjsong95@gmail.com

0422209291

Facility Contacts

Myeong Jun Song

Role: primary

8242-220-9291

Other Identifiers

Gilead IN-US-320-4407

Identifier Type: -

Identifier Source: org_study_id