Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

Antiviral Efficacy of Continuing Lamivudine Plus Adefovir or Switching to Telbivudine Plus Adefovir in HBeAg-positive Lamivudine-refractory Chronic Hepatitis B Patients Who Have Suboptimal Response to Lamivudine Plus Adefovir for at Least 12 Months

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01270165
• Other study ID #: 4-2010-0168
• Status: Recruiting
• Phase: Phase 3
• First received: January 4, 2011
• Last updated: January 31, 2012
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: January 2012
• Source: Yonsei University
• Contact: Han Jak Ryu, Dr.
• Phone: +82-10-2329-2379
• Email: hanjak[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Republic of Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• HBeAg positive

• lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for YMDD positive patients

• HBV DNA over 300 copies/ml

Exclusion Criteria:

• decompensated cirrhosis

• renal failure

• prior interferon usage

• evidence of HCC or prior organ transplantation

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• telbivudine
600mg, oral daily over 12 months

Locations

Country	Name	City	State
Korea, Republic of	Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic response		1 year	Yes
Secondary	Safety, virologic breakthrough and biochemical response		1 year	Yes