Hepatitis B, Chronic Clinical Trial
Official title:
Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA
Verified date | May 2012 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.
Status | Completed |
Enrollment | 72 |
Est. completion date | November 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with = HBV DNA 60 IU/mL level and HBeAg positive at baseline. Exclusion Criteria: - All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study. - Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study. - Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma. - Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV. - Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pusan National University School of Medicine | Busan | |
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University | Pusan National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy | at Week 96 | No | |
Secondary | Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy | at Week 48 | No | |
Secondary | Percentage number of patients who developed drug resistant mutations while on randomized therapy | at Week 48 and Week 96 | No | |
Secondary | Change from baseline in mean HBV DNA | at Week 48 and 96 | No | |
Secondary | Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion | at Week 48 and 96 | No | |
Secondary | Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment | Follow up period | Yes |
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