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

NCT02533544 | Completed

• 1 other identifier: IN-US-174-1805
• Study Type: observational
• Target: 572
• Locations: 1 country
• Sites: 1

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

Keywords

tenofovir disoproxil fumarate

Outcome Measures

Primary Outcomes (2)

• The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48

  proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48

  week 48

• The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96

  proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96

  Week 96

Secondary Outcomes (9)

• The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits

  week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

• The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96

  Week 48 and 96

• The proportion of the serological response (loss of HBeAg and seroconversion to HBeAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96

  Week 48 and 96

• The proportion of the serological response (loss of HBsAg and seroconversion to HBsAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96

  Week 48 and 96

• The change from baseline in the decline of HBV DNA at every visits

  week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144

Study Arms (1)

tenofovir disoproxil fumarate monotherapy

a group which treated with tenofovir disoproxil fumarate

Drug: tenofovir disoproxil fumarate

Interventions

tenofovir disoproxil fumarate DRUG

tenofovir disoproxil fumarate monotherapy

Eligibility Criteria

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

Study Population

Secondary and Tertiary hospital

You may qualify if:

• Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
• 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).
• Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months)
• 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)
• 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

You may not qualify if:

• Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
• Co-infection with HCV, HIV
• Evidence of hepatocellular carcinoma (e.g. α-fetoprotein\> 50 ng/mL or as evidenced by recent ultrasound or other standard of care measure)
• 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
• Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
• Currently receiving therapy with cytotoxic agent, nephrotoxic agents, or agents capable of modifying renal excretion
• 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.

Sponsors & Collaborators

• Myeong Jun Song: lead
• Gilead Sciences: collaborator
• Wonkwang University: collaborator
• Soonchunhyang University Hospital: collaborator
• Chungnam National University Hospital: collaborator
• Konyang University Hospital: collaborator

Study Sites (1)

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

Junggu, Daejeon, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30725293 DERIVED

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

• Myeong Jun Song, Ph.D. M.D.

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 27, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

KR (1)