Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B

Myeong Jun Song

Status: Completed

Conditions: Chronic Hepatitis B

Treatments: Drug: tenofovir disoproxil fumarate

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02533544

IN-US-174-1805

Details and patient eligibility

About

This is an open-label, single arm cohort study to see efficacy and safety of tenofovir disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively both.

Enrollment: 572 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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, 19 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. Chronic hepatitis B with the following:

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

5. A patient who treating with TDF as a treatment-naïve for Hepatitis B. 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

6. Decompensated liver cirrhosis defined based on a Child-Turcotte-Pugh (CTP) score ≥ 7 (Child B and C) or presence with at least one episode of ascites, jaundice, hepatic encephalopathy or variceal bleeding

7. Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit

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

Exclusion criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in the study.

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.

Trial design

572 participants in 1 patient group

tenofovir disoproxil fumarate monotherapy

Description:

a group which treated with tenofovir disoproxil fumarate

Treatment:

Drug: tenofovir disoproxil fumarate