A Phase 4 interventional study of Lamivudine plus adefovir and Tenofovir in Chronic Hepatitis B, sponsored by Keimyung University Dongsan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-28.
Sponsored by Keimyung University Dongsan Medical Center · Phase 4, Interventional, and Treatment
This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B patients with Undetectable Hepatitis B Virus DNA
Recently, in Korea, long-term medication of antiviral agents and their resulting resistance expression have been the most serious cause of failure to treat chronic hepatitis B. Exp.
In particular, the annual resistance rate to lamivudine currently widely being used in Korea amounts to about 15 to 20 percents and the rate is expected to reach 70 to 80 percent in four to five years.
The guidelines by the American Association for the Study of Liver Disease (AASLD) and the European Association for the Study of the Liver (EASL) recommend a combination therapy with adefovir or tenofovir for patients with lamivudine resistant HBV .
In Korea, however, in case of combined prescription of lamivudine and adefovir, only one of them is covered by the health insurance and therefore many patients are difficult to continue treatment due to their economic conditions.
Tenofovir that has been developed most recently and will be placed on sale sooner or later in Korea has strong antiviral effects, causes little or no emergence of resistant viruses, and is known to have lower nephrotoxicity than adefovir.
In particular, several papers reported that tenofovir has effective and sustaining antiviral effects in patients who had other antiviral agents resistant HBV as well as those who received initial treatment. This shows that patients only with lamivudine resistant HBV can be treated only with tenofovir without a combination therapy and when they have low levels of HBV DNA, treatment is relatively effective despite their resistance to adefovir.
Therefore, it is considered that tenofovir switching therapy in patients with undetectable HBV DNA after lamivudine plus adefovir combination therapy to maintain their virus response.
The results of this study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in such patients.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 171 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Keimyung University Dongsan Medical Center is the lead sponsor of 81 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Continue lamivudine/adefovir add on treatment (standard treatment)
Drug: Lamivudine plus adefovir
Switch from lamivudine/adefovir add on treatment to tenofovir monotherapy
Drug: Tenofovir
Lamivudine 100mg QD for 96 weeks + Adefovir 10mg QD for 96 weeks
Also known as: Zeffix, Hepsera
Tenofovir 300mg QD for 96 weeks
Also known as: Viread
Percentage number of patients with virus reactivation
Percentage number of patients with virus reactivation (HBV DNA \> 40 IU/mL on two consecutive samples taken 1 month apart, or persistent HBV DNA levels of 20-40 IU/mL on three consecutive 1 month interval) at Week 96 while on treatment.
Time frame: Week 96 while on treatment
Virologic response
Virologic response Percentage number of patients with virus reactivation at Week 48
Time frame: Week 96 while on treatment
Antiviral resistance
Antiviral resistance percentage number of patients who developed drug resistant mutation at Week 48 and 96 while on randomized therapy.
Time frame: Week 96 while on treatment
Biochemical response
Biochemical response percentage number of patients with biochemical breakthrough at Week 48 and 96
Time frame: Week 96 while on treatment
Serologic response
Serologic response (1) HBeAg loss/seroconversion in HBeAg-positive CHB Percentage number of patients with HBeAg loss or seroconversion at Week 48 and 96.
Time frame: Week 96 while on treatment
Safety assessment
Safety assessment
Time frame: Week 96 while on treatment
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Keimyung University Dongsan Medical Center