Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B

Hepatitis B, Chronic Clinical Trial

Official title:

Efficacy and Safety of Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus Adefovir or Adefovir Monotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02482272
• Other study ID #: ENTADE
• Status: Recruiting
• Phase: Phase 4
• First received: June 1, 2015
• Last updated: December 29, 2015
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: December 2015
• Source: Asan Medical Center
• Contact: Danbi Lee
• Phone: 82)2-3010-3907
• Email: leighdb[@]hanmail.net
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or Adefovir

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Chronic hepatitis B

• Age = 20 year old

• Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks

• Proven Lamivudine resistant mutation

• HBV DNA levels at screening = 15 IU/mL

• Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test

• Patient is able to give written informed consent prior to study start and to comply with the study requirements

Exclusion Criteria:

• A history or current of decompensated cirrhosis or hepatocellular carcinoma

• Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy

• Co-infected with HCV or HIV

• A history of organ transplantation

• Pregnant or breast-feeding

• Current clinically relevant of abuse of alcohol or drugs.

• Significant immunocompromised, gastrointestinal, renal(serum creatinine = 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy

• malignancy in previous 5 years

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lamivudine
Lamivudine 100mg/day orally
• Adefovir
Adefovir 10mg/day orally
• Entecavir
Entecavir 1mg/day orally

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with HBV DNA<15IU/mL		week 48	No
Secondary	Proportion of patients with HBV DNA<15IU/mL		Day1, week12, week 24, week 36, week 48	No
Secondary	The change of HBV DNA from the baseline		week 48	No
Secondary	Proportion of patients with ALT normalization		Day1, week12, week 24, week 36, week 48	No
Secondary	Proportion of patients with HBeAg loss and/or seroconversion		Day1, week12, week 24, week 36, week 48	No
Secondary	The change of HBsAg from the baseline		week 48	No
Secondary	Proportion of patients with HBsAg loss and/or seroconversion		week 24, week 48	No
Secondary	Proportion of patients who experienced virologic breakthrough		week 48	No
Secondary	Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs)	Composite outcome measure consisting of multiple measures, including: Number of patients with Adverse events( including SAEs); Frequency and severity of Abnormalities in laboratory examinations; BUN, Albumin, AST, ALT,GGT, Creatinine, Hemoglobin, Hematocrit, Platelet Count, Prothrombin time; Number of patients with Abnormalities in physical examinations; Eyes/Ears/Nose/Throat, Respiratory, Cardiovascular, Dermatological, Abdominal, Musculoskeletal, Other; Number of patients with Abnormalities in vital signs ; pulse rate( beats per minute), Blood pressure(mmHg), Height(cm), weight(kg)	week 48	Yes