Status:
COMPLETED
A Two-year Study of Telbivudine in HBeAg Negative Hepatitis
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsors:
Guangdong Provincial People's Hospital
Guangzhou 8th People's Hospital
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an individualized telbivudine treatment roadmap strategy designed to achieve optimal viral suppression and low...
Detailed Description
This study is an open-label, multicenter, PCR response adaptive clinical study design, with intensification of treatment (addition of adefovir to telbivudine treatment) depending on HBV DNA level at w...
Eligibility Criteria
Inclusion
- Detectable serum HBsAg at the Screening visit and at least 6 months prior
- HBeAg negative at Screening visit
- serum HBV DNA level \>2,000 IU/mL at Screening visit
- Elevated serum ALT≥2 ×ULN and \<10×ULN at Screening visit (excluding ALT elevations due to non-HBV reasons such as drug, alcohol etc)
Exclusion
- Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
- Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)\>50ng/mL.
- Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
- Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.
- Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
- Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
- Patient has used hepatotoxic drugs within one month.
- Patient has overtaken alcohol (\>40g/day) or abused illicit drugs in recent one year.
- Use of other investigational drugs at the time of enrollment.
- History of hypersensitivity to any of the study drugs (telbivudine or adefovir).
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
- Patient is co-infected with HCV, HDV or HIV.
- Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis).
- History of malignancy of any organ system.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2014
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01521975
Start Date
January 1 2011
End Date
May 30 2014
Last Update
October 24 2017
Active Locations (1)
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1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630