Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

Hepatitis B, Chronic Clinical Trial

Official title:

Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013272
• Other study ID #: HKUHEP-01
• Status: Completed
• Phase: N/A
• First received: November 12, 2009
• Last updated: November 30, 2015
• Start date: June 2007
• Est. completion date: July 2010

Study information

• Verified date: November 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. They will be eligible if their liver tests are normal and their viral load is undetectable. Patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis B virus after successful treatment with entecavir. Patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. If there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with chronic hepatitis B treated with entecavir for 6 months or more

• Normal ALT

• Undetectable HBV DNA by Roche Taqman PCR Assay

• No other previous therapy with nucleoside/nucleotide analogues

Exclusion Criteria:

• Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease

• History of hepatocellular carcinoma

• History of decompensated liver disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis B, Chronic

Intervention

Drug:
• Entecavir
Entecavir 0.5mg orally daily
• Lamivudine
Lamivudine 100mg orally, daily

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load		96 weeks	No
Secondary	Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load		96 weeks	No