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

A

Asan Medical Center

Status and phase

Unknown
Phase 4

Conditions

Hepatitis B, Chronic

Treatments

Drug: Lamivudine
Drug: Entecavir
Drug: Adefovir

Study type

Interventional

Funder types

Other

Identifiers

NCT02482272
ENTADE

Details and patient eligibility

About

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

Enrollment

90 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Lamivudine plus Adefovir or Adefovir
Active Comparator group
Description:
Lamivudine+Adefovir or Adefovir for 48 weeks
Treatment:
Drug: Adefovir
Drug: Lamivudine
Entecavir plus Adefovir
Experimental group
Description:
Entecavir+Adefovir for 48 weeks
Treatment:
Drug: Entecavir
Drug: Adefovir

Trial contacts and locations

0

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Central trial contact

Danbi Lee

Data sourced from clinicaltrials.gov

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