Study for Consolidation Period of Chronic Hepatitis B

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Tainan Municipal Hospital
Sponsor:
Information provided by (Responsible Party):
Tainan Municipal Hospital
ClinicalTrials.gov Identifier:
NCT01732354
First received: November 18, 2012
Last updated: November 21, 2012
Last verified: November 2012
  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
HBeAg Seroconversion

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.

  • HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    avoiding long-term inevitable serological or virological recurrence.


Other Outcome Measures:
  • Loss of HBsAg and appearance of HBsAb [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Loss of HBsAg means complete recovery of HBV infection


Estimated Enrollment: 136
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2013 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

136 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.

No Contacts or Locations Provided
  More Information

No publications provided

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: November 21, 2012
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human

ClinicalTrials.gov processed this record on September 18, 2014