Clinical trial NCT01264354: An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
Official title: An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.


Eligibility criteria: Inclusion Criteria:

* Patient is 18 years and older.
* Patient is documented to be HBsAg positive for \> 6 months.
* Patient is HBV DNA positive with DNA levels ≥ 1×10\^5 copies/mL within 30days of baseline.
* Patient has ALT levels ≥ 1×ULN
* Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

* Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
* Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
* Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.
* Patient with clinical evidence of decompensated liver disease (Total bilirubin \< 2.0mg/dL, Prothrombin time \< 1.7(INR), Serum albumin≥3.5g/dL)
* Patient is coinfected with HCV, HDV or HIV.
* Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
* Patient with clinical evidence of hepatocellular carcinoma
* Patient with previous liver transplantation
* Patient is pregnant or breast-feeding.
* Patient has a clinically relevant history of abuse of alcohol or drugs.
* Patient has a significant immunocompromised, gastrointestinal, renal,
* hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
* Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Primary outcomes:
measure: Proportion of patients with HBV DNA levels < 300 copies/mL
timeFrame: 24 week
Secondary outcomes:
measure: The change of HBV DNA form the baseline
timeFrame: 24week, 48week, 96week
measure: Proportion of patients with HBV DNA < 300 copies/mL
timeFrame: 48week, 96week
measure: Proportion of patients with ALT normalization
timeFrame: 24week, 48week, 96week
measure: Proportion of patients with HBeAg loss and/or seroconversion
timeFrame: 96 Week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: