Status:
UNKNOWN
HBsAg Related Response Guided Therapy
Lead Sponsor:
Gangnam Severance Hospital
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up) Seconda...
Detailed Description
After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups. * HBsAg \>20,000 : study termination * Group A :1,500\<HBsAg≤ 20,000 ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA(patients must have \> 100,000 copies/ml as measured by PCR) and anti-HBs negative
- Elevated serum ALT \> 2ULN but ≤ 10 × ULN as determined by two abnormal values taken ≥ 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.
Exclusion
- Patients must not have received antiviral therapy for their chronic hepatitis B. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had less than 6 months treatment of NA(Nucleos(t)ide analog) and more than 1 year wash-out period for systemic antiviral therapy and negative results in the NA resistance test at baseline are not excluded.
- Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab.
- Diagnosed hepatic cellular carcinoma
- Any evidence of decompensated liver disease (Childs B-C)
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01456312
Start Date
September 1 2012
End Date
August 1 2016
Last Update
October 31 2012
Active Locations (1)
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1
Shinchon Severance Hospital
Seoul, Seoul, South Korea, 120742