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Trial registered on ANZCTR


Registration number
ACTRN12612001299897
Ethics application status
Approved
Date submitted
13/12/2012
Date registered
17/12/2012
Date last updated
17/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Using Quantitative HBs Antigen Levels in the Therapy of Patients with Hepatitis B Infection
Scientific title
Monitoring the Quantitative HBsAg Levels in Guiding the Efficacy of Chronic Hepatitis B Therapies
Secondary ID [1] 281662 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Therapy of Chronic Hepatitis B virus infection 287953 0
Condition category
Condition code
Infection 288335 288335 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 288336 288336 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1, Arm- Newly diagnosed chronic hepatitis B patients starting to receive pegylated interferon (PEG-IFN in a dose of 1.5 mcg per kg subcutaneously once weekly or 180 mcg subcutaneously once weekly, for 48 weeks) based therapies in our Hepatology Clinic.
2, Arm- Newly diagnosed chronic hepatitis B patients starting to receive nucleos(t)ide analogues (NAs:lamivudine 100 mg orally once daily, telbivudine 600 mg orally once daily, tenofovir 245 mg orally once daily, entecavir 0.5 mg orally once daily, until the HBe seroconversion occurs in HBeAg positive patients or until the HBs seroconversion occurs in Anti HBe antibody positive patients) in our Hepatology Clinic.
Intervention code [1] 286201 0
Not applicable
Comparator / control treatment
There is no control group. In Turkey hepatitis B virus infection is treated either by pegylated interferon or oral antiviral tablets (lamivudin, entecavir, tenofovir, telbivudin). In this study we aim to observe and follow up all those patients with regard to their HBs antigen titrarion. In another word all HBV patients under treatment will be observed. So, both arms under observation are of 'equal weight'?
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288502 0
Primary Outcome 1: The value of quantitative HBS Ag titer in predicting the HBsAg clearance and HBsAg seroconversion, defined as HBsAg disappearance and anti-HBs antibody appearance.
Timepoint [1] 288502 0
Timepoint 1: Will be assessed at baseline, 4, 8, 12, 24, 36, 48, 52, 64, 72, 84, 100 weeks after the initiation of therapies (oral antiviral therapy or pegylated interferon).
Primary outcome [2] 288503 0
Primary Outcome 2: The value of quantitative HBS Ag titer in predicting the Virologic response, defined as decrease in serum HBV DNA to undetectable levels by PCR assays, and loss of HBeAg in patients who were initially HBeAg positive.
Timepoint [2] 288503 0
Timepoint 2: Will be assessed at baseline 4, 12, 24, 48, 72, 84, 100 weeks after the initiation of therapies (oral antiviral therapy or pegylated interferon).
Primary outcome [3] 288504 0
Primary Outcome 3: Sustained off-treatment virological response, defined as HBV DNA levels below 2000 IU/ml for at least 12 months after the end of therapy with the sustained llow titers of quantitative HBS Ag.
Timepoint [3] 288504 0
Timepoint 3: Will be assessed at baseline, 64, 72, 84, 100 weeks after the initiation of therapies (oral antiviral therapy or pegylated interferon).
Secondary outcome [1] 300337 0
Secondary Outcome 1: Serological response for HBeAg, only to patients with HBeAg-positive CHB and is defined as HBeAg loss and seroconversion to anti-HBe.
Timepoint [1] 300337 0
Timepoint 1: Will be assessed at baseline 4, 12, 24, 48, 72, 84, 100 weeks after the initiation of therapies (oral antiviral therapy or pegylated interferon).
Secondary outcome [2] 300338 0
Secondary Outcome 2: Biochemical response, defined as normalisation of ALT levels.
Timepoint [2] 300338 0
Timepoint 2: Will be assessed at 4, 8, 12, 24, 36, 48, 52, 64, 72, 84, 100 weeks after the start of therapies.

Eligibility
Key inclusion criteria
Treatment-naive-hepatitis B virus infection patients for whom a treatment plan has been made by the hepatology outpatient clinic. (Indication for treatment is the presence of HBs Ag in serum for more than 6 months, and by liver biopsy showing histological features of chronic hepatitis compatible with HBV infection.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior antiviral therapy
- Immunosuppressive therapy within the previous 6 months
- Presence of viral coinfections,with hepatitis C, hepatitis D, or human immunodeficiency virus;
- Presence of other acquired or inherited causes of liver disease

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4747 0
Turkey
State/province [1] 4747 0

Funding & Sponsors
Funding source category [1] 286459 0
University
Name [1] 286459 0
Gastroenterology Institute of Marmara University
Country [1] 286459 0
Turkey
Primary sponsor type
University
Name
Gastroenterology Institute of Marmara University
Address
P.K.53, Basibuyuk-Maltepe, 34840 Istanbul, Turkey
Country
Turkey
Secondary sponsor category [1] 285247 0
None
Name [1] 285247 0
Address [1] 285247 0
Country [1] 285247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288536 0
Marmara University School of Medicine Ethics Committee
Ethics committee address [1] 288536 0
Marmara University School of Medicine Ethics Committee, Tibbiye Cad., No:49 81326 Haydarpasa/ Istanbul
Ethics committee country [1] 288536 0
Turkey
Date submitted for ethics approval [1] 288536 0
Approval date [1] 288536 0
20/09/2012
Ethics approval number [1] 288536 0
09.2012.0118

Summary
Brief summary
The aim of this study is to focus on the clinical utility of hepatitis B surface antigen (HBsAg) quantitation by assessing on-treatment serum HBsAg kinetics in newly diagnosed HBeAg-negative and positive chronic hepatitis B (CHB) patients who will be treated with pegylated interferon-based therapies or nucleos(t)ide analogues as endicated in our Hepatology Clinic.

We suggest that approximately 100 eligible CHB patients will participate and be followed up during 3 years in this prospective analysis.

Serum hepatitis B virus (HBV) DNA, liver chemistry tests and HBsAg (Abbott Architect HBsAg QT assay) will be assessed at baseline and during treatment (weeks 0, 4, 8, 12, 24, 36, 48, 52, 64, 72, 84, 100).

Decline in HBsAg and HBV DNA over time will be determined, results will be stratified according to treatment groups and baseline characteristics and then analyzed with regard to our primary and secondary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36586 0
A/Prof Deniz Guney Duman
Address 36586 0
Marmara University School of Medicine, Mimar Sinan Cad., Fevzicakmak mah., No: 41 Ust Kaynarca
34899 PENDIK /ISTANBUL/ TURKEY
Country 36586 0
Turkey
Phone 36586 0
+90 (216) 625 46 84
Fax 36586 0
Email 36586 0
[email protected]
Contact person for public queries
Name 36587 0
Deniz Guney Duman
Address 36587 0
Marmara University School of Medicine, Mimar Sinan Cad., Fevzicakmak mah., No: 41 Ust Kaynarca
34899 PENDIK /ISTANBUL/ TURKEY
Country 36587 0
Turkey
Phone 36587 0
+90 (216) 625 46 84
Fax 36587 0
Email 36587 0
[email protected]
Contact person for scientific queries
Name 36588 0
Deniz Guney Duman
Address 36588 0
Marmara University School of Medicine, Mimar Sinan Cad., Fevzicakmak mah., No: 41 Ust Kaynarca
34899 PENDIK /ISTANBUL/ TURKEY
Country 36588 0
Turkey
Phone 36588 0
+90 (216) 625 46 84
Fax 36588 0
Email 36588 0
[email protected]

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