Study for Consolidation Period of Chronic Hepatitis B

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tainan Municipal Hospital
ClinicalTrials.gov Identifier:
NCT01732354
First received: November 18, 2012
Last updated: May 2, 2016
Last verified: May 2016
  Purpose
The investigators aim to clarify the issue of adequate duration of consolidation period of Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.

Condition
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Investigate the Consolidation Period of 12 Months Compared to 18 Months After Tenofovir Therapy With HBeAg Seroconversion in Asian Chronic Hepatitis B HBeAg-positive Patients

Resource links provided by NLM:


Further study details as provided by Tainan Municipal Hospital:

Primary Outcome Measures:
  • HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    We aim to clarify the issue of adequate duration of consolidation period which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.


Enrollment: 137
Study Start Date: November 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Detailed Description:

According to practice guidelines of American Association of the Study of Liver Diseases, in patients of HBeAg-positive chronic hepatitis B, treatment should be continued until the patient has achieved HBeAg seroconversion and undetectable serum HBV DNA and completed at least 6 months of additional treatment after appearance of anti-HBe. Also several other current guidelines of anti-viral treatment of chronic hepatitis B infection suggest that nucleos (t) ide analogues treatment can be stopped following 6 to 12 months of consolidation therapy after HBeAg seroconversion. However, there is a paucity of data available about the long-term durability of Tenofovir induced HBeAg seroconversion as well as antiviral treatment associated resistance risk.

2. Primary end points: HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb. Serological recurrence was defined as reappearance of HBeAg. Virological recurrence was defined as an increase of HBV DNA level to greater than 10,000 copies/mL after HBeAg seroconversion with previously HBV DNA levels less than 10,000 copies/mL.

3. Aims: To clarify the issue of adequate duration of consolidation period which could strike a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or virological recurrence.

4. Study design: A single-center cohort study which randomly allocating two different extended TDF treatment periods after HBeAg seroconversion - 12 months, and 18 months across patient groups. Then data will be collected about outcomes at a specific follow-up time.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
137 patients
Criteria

Inclusion Criteria:

  • adult patients with chronic HBV infection (HBsAg-positivity for at least six months and HBeAg-positivity for at least three months) and serum HBV DNA levels ≥1000000 copies/ml (Cobas Amplicor HBV Monitor assay) at screening as well as serum ALT levels >1.3 times the ULN (43 IU/L) on at least two occasions in the previous 6 months and at screening.

Exclusion Criteria:

  • co-infection with HCV, HDV, or HIV and treatment with (pegylated) interferon or other nucleos (t) ide analogues for less than six months before the start of Tenofovir treatment.
  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: NCT01732354

Locations
Taiwan
Chun-Hsiang Wang
Tainan, Taiwan, 701
Sponsors and Collaborators
Tainan Municipal Hospital
  More Information

Responsible Party: Tainan Municipal Hospital
ClinicalTrials.gov Identifier: NCT01732354     History of Changes
Other Study ID Numbers: IX-US-174-0206 
Study First Received: November 18, 2012
Last Updated: May 2, 2016
Health Authority: Taiwan: Department of Health

Keywords provided by Tainan Municipal Hospital:
Hepatitis B virus, Tenofovir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
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 July 28, 2016