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Study for Consolidation Period of Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT01732354
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Tainan Municipal Hospital

Tracking Information
First Submitted Date November 18, 2012
First Posted Date November 22, 2012
Last Update Posted Date April 19, 2018
Actual Study Start Date September 2012
Actual Primary Completion Date November 20, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2014)
HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb. [ Time Frame: 3 years ]
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.
Original Primary Outcome Measures
 (submitted: November 21, 2012)
  • HBeAg seroconversion was defined as loss of HBeAg with concurrent appearance of HBeAb. [ Time Frame: 3 years ]
    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 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: November 21, 2012)
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 ]
avoiding long-term inevitable serological or virological recurrence.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 21, 2012)
Loss of HBsAg and appearance of HBsAb [ Time Frame: 3 years ]
Loss of HBsAg means complete recovery of HBV infection
 
Descriptive Information
Brief Title Study for Consolidation Period of Chronic Hepatitis B
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
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 137 patients
Condition Hepatitis B
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 2, 2016)
137
Original Estimated Enrollment
 (submitted: November 21, 2012)
136
Actual Study Completion Date April 18, 2018
Actual Primary Completion Date November 20, 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01732354
Other Study ID Numbers IX-US-174-0206
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tainan Municipal Hospital
Study Sponsor Tainan Municipal Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Tainan Municipal Hospital
Verification Date April 2018