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Trial record 61 of 344 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by The Catholic University of Korea
Sponsor:
Collaborators:
Gilead Sciences
Wonkwang University
Soonchunhyang University Hospital
Chungnam National University Hospital
Konyang University Hospital
Information provided by (Responsible Party):
Myeong Jun Song, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT02533544
First received: August 17, 2015
Last updated: June 1, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Chronic Hepatitis B
Drug: tenofovir disoproxil fumarate

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B : a Real Life Multicenter Cohort Study in Korea

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48

  • The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96


Secondary Outcome Measures:
  • The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits [ Time Frame: week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ] [ Designated as safety issue: No ]
    The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits

  • The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]
    The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at 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 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]
    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

  • The change from baseline in the decline of HBV DNA at every visits [ Time Frame: week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 ] [ Designated as safety issue: No ]
    The change from baseline in the decline of HBV DNA at every visits

  • The proportion of patients showing virological breakthrough at week 48 and 96 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]

    The proportion of patients showing virological breakthrough at week 48 and 96.

    Virological Breakthrough defined as any increase in serum HBV DNA by >1 log10 from nadir or redetection of serum HBV DNA at levels ≥10-fold the lower limit of detection of the HBV DNA assay after having an undetectable result


  • The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]

    The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96.

    Virological Breakthrough defined as any increase in serum HBV DNA by >1 log10 from nadir or redetection of serum HBV DNA at levels ≥10-fold the lower limit of detection of the HBV DNA assay after having an undetectable result


  • The proportion of improvement of liver function including Child Score, Model for End-stage Liver Disease (MELD) score at Week 48 and 96 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]
    The proportion of improvement of liver function including Child Score, MELD score at Week 48 and 96

  • The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]
    The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96


Estimated Enrollment: 500
Study Start Date: October 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
tenofovir disoproxil fumarate monotherapy
a group which treated with tenofovir disoproxil fumarate
Drug: tenofovir disoproxil fumarate

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Secondary and Tertiary hospital
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:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02533544

Contacts
Contact: Myeong Jun Song, Ph.D. M.D. 8242-220-9291 mjsong95@gmail.com

Locations
Korea, Republic of
The Catholic University of Korea, Daejeon St.Mary's Hosptial Recruiting
Junggu, Daejeon, Korea, Republic of
Contact: Myeong Jun Song    8242-220-9291      
Sponsors and Collaborators
Myeong Jun Song
Gilead Sciences
Wonkwang University
Soonchunhyang University Hospital
Chungnam National University Hospital
Konyang University Hospital
Investigators
Principal Investigator: Myeong Jun Song, Ph.D. M.D. The Catholic University of Korea
  More Information

Responsible Party: Myeong Jun Song, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02533544     History of Changes
Other Study ID Numbers: IN-US-174-1805 
Study First Received: August 17, 2015
Last Updated: June 1, 2016
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by The Catholic University of Korea:
tenofovir disoproxil fumarate

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on December 05, 2016