Trial record 138 of 511 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Young-Hwa Chung, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT02482272
First received: June 1, 2015
Last updated: December 29, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Hepatitis B, Chronic
Drug: Lamivudine
Drug: Adefovir
Drug: Entecavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Proportion of patients with HBV DNA<15IU/mL [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with HBV DNA<15IU/mL [ Time Frame: Day1, week12, week 24, week 36, week 48 ] [ Designated as safety issue: No ]
  • The change of HBV DNA from the baseline [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • Proportion of patients with ALT normalization [ Time Frame: Day1, week12, week 24, week 36, week 48 ] [ Designated as safety issue: No ]
  • Proportion of patients with HBeAg loss and/or seroconversion [ Time Frame: Day1, week12, week 24, week 36, week 48 ] [ Designated as safety issue: No ]
  • The change of HBsAg from the baseline [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • Proportion of patients with HBsAg loss and/or seroconversion [ Time Frame: week 24, week 48 ] [ Designated as safety issue: No ]
  • Proportion of patients who experienced virologic breakthrough [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs) [ Time Frame: week 48 ] [ Designated as safety issue: Yes ]

    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)


Estimated Enrollment: 90
Study Start Date: May 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Young-Hwa Chung, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02482272     History of Changes
Other Study ID Numbers: ENTADE 
Study First Received: June 1, 2015
Last Updated: December 29, 2015
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
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

ClinicalTrials.gov processed this record on August 25, 2016