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

NCT ID: NCT02533544

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 572 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-10-31

Brief Summary

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.

Conditions

Chronic Hepatitis B

Study Design

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

Study Groups

tenofovir disoproxil fumarate monotherapy

a group which treated with tenofovir disoproxil fumarate

tenofovir disoproxil fumarate

Intervention Type: DRUG

Interventions

tenofovir disoproxil fumarate

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, 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

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: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Wonkwang University

OTHER

Sponsor Role: collaborator

Soonchunhyang University Hospital

OTHER

Sponsor Role: collaborator

Chungnam National University Hospital

OTHER

Sponsor Role: collaborator

Konyang University Hospital

OTHER

Sponsor Role: collaborator

Myeong Jun Song

OTHER

Sponsor Role: lead

Responsible Party

Myeong Jun Song

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Myeong Jun Song, Ph.D. M.D.

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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

Junggu, Daejeon, South Korea

Countries

South Korea

References

Kwon JH, Song MJ, Jang JW, Bae SH, Choi JY, Yoon SK, Kim HY, Kim CW, Song DS, Chang UI, Yang JM, You CR, Choi SW, Lee HL, Lee SW, Han NI, Nam SW, Kim SG, Kim YS, Kim SH, Lee BS, Lee TH, Cho EY. Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naive Patients with Chronic Hepatitis B in Korea. Dig Dis Sci. 2019 Jul;64(7):2039-2048. doi: 10.1007/s10620-019-05489-7. Epub 2019 Feb 6.

Reference Type: DERIVED

PMID: 30725293 (View on PubMed)

Other Identifiers

IN-US-174-1805

Identifier Type: -

Identifier Source: org_study_id