An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

Phase 4

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Clevudine 20mg+Adefovir dipivoxil 10mg; Drug: Clevudine 30mg; Drug: Clevudine 20mg

• Registration Number: NCT01264354
• Lead Sponsor: Bukwang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-12-19
• Study First Submitted QC: 2010-12-19
• Study First Posted: 2010-12-21
• Primary Completion: 2012-08
• Study Completion: 2013-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Clevudine 20mg+Adefovir dipivoxil 10mg	Clevudine 20mg+Adefovir dipivoxil 10mg
1	Clevudine 30mg	Clevudine 30mg
3	Clevudine 20mg	Clevudine 20mg

Primary Outcome Measures

Name	Time	Method
Proportion of patients with HBV DNA levels < 300 copies/mL	24 week

Secondary Outcome Measures

Name	Time	Method
The change of HBV DNA form the baseline	24week, 48week, 96week	(log copies/mL)
Proportion of patients with HBV DNA < 300 copies/mL	48week, 96week
Proportion of patients with ALT normalization	24week, 48week, 96week
Proportion of patients with HBeAg loss and/or seroconversion	96 Week

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of