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

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ClinicalTrials.gov Identifier: NCT02482272
Recruitment Status : Unknown
Verified December 2015 by Young-Hwa Chung, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : June 26, 2015
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Young-Hwa Chung, Asan Medical Center

Brief 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

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Lamivudine Drug: Adefovir Drug: Entecavir Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lamivudine plus Adefovir or Adefovir
Lamivudine+Adefovir or Adefovir for 48 weeks
Drug: Lamivudine
Lamivudine 100mg/day orally

Drug: Adefovir
Adefovir 10mg/day orally

Experimental: Entecavir plus Adefovir
Entecavir+Adefovir for 48 weeks
Drug: Adefovir
Adefovir 10mg/day orally

Drug: Entecavir
Entecavir 1mg/day orally




Primary Outcome Measures :
  1. Proportion of patients with HBV DNA<15IU/mL [ Time Frame: week 48 ]

Secondary Outcome Measures :
  1. Proportion of patients with HBV DNA<15IU/mL [ Time Frame: Day1, week12, week 24, week 36, week 48 ]
  2. The change of HBV DNA from the baseline [ Time Frame: week 48 ]
  3. Proportion of patients with ALT normalization [ Time Frame: Day1, week12, week 24, week 36, week 48 ]
  4. Proportion of patients with HBeAg loss and/or seroconversion [ Time Frame: Day1, week12, week 24, week 36, week 48 ]
  5. The change of HBsAg from the baseline [ Time Frame: week 48 ]
  6. Proportion of patients with HBsAg loss and/or seroconversion [ Time Frame: week 24, week 48 ]
  7. Proportion of patients who experienced virologic breakthrough [ Time Frame: week 48 ]
  8. Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs) [ Time Frame: week 48 ]

    Composite outcome measure consisting of multiple measures, including:

    1. Number of patients with Adverse events( including SAEs)
    2. Frequency and severity of Abnormalities in laboratory examinations; BUN, Albumin, AST, ALT,GGT, Creatinine, Hemoglobin, Hematocrit, Platelet Count, Prothrombin time
    3. Number of patients with Abnormalities in physical examinations; Eyes/Ears/Nose/Throat, Respiratory, Cardiovascular, Dermatological, Abdominal, Musculoskeletal, Other
    4. Number of patients with Abnormalities in vital signs ; pulse rate( beats per minute), Blood pressure(mmHg), Height(cm), weight(kg)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482272


Contacts
Contact: Danbi Lee 82)2-3010-3907 leighdb@hanmail.net

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Young Hwa Chung         
Sponsors and Collaborators
Asan Medical Center

Responsible Party: Young-Hwa Chung, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02482272     History of Changes
Other Study ID Numbers: ENTADE
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Lamivudine
Adefovir
Adefovir dipivoxil
Entecavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents