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

Sponsor

Bukwang Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT01264354

Collaborator

(none)

Enrollment

Location

Arms

35.1

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: Clevudine 30mg Drug: Clevudine 20mg+Adefovir dipivoxil 10mg Drug: Clevudine 20mg	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Clevudine 30mg	Drug: Clevudine 30mg Clevudine 30mg Other Names: Levovir 30mg
Experimental: 2 Clevudine 20mg+Adefovir dipivoxil 10mg	Drug: Clevudine 20mg+Adefovir dipivoxil 10mg Clevudine 20mg+ Adefovir 10mg Other Names: Levovir 20mg+Adefovir 10mg
Experimental: 3 Clevudine 20mg	Drug: Clevudine 20mg Clevudine 20mg Other Names: Levovir 20mg

Arm

Intervention/Treatment

Experimental: 1

Clevudine 30mg

Drug: Clevudine 30mg

Clevudine 30mg

Other Names:

Levovir 30mg

Experimental: 2

Clevudine 20mg+Adefovir dipivoxil 10mg

Drug: Clevudine 20mg+Adefovir dipivoxil 10mg

Clevudine 20mg+ Adefovir 10mg

Other Names:

Levovir 20mg+Adefovir 10mg

Experimental: 3

Clevudine 20mg

Drug: Clevudine 20mg

Clevudine 20mg

Other Names:

Levovir 20mg

Outcome Measures

Primary Outcome Measures

Proportion of patients with HBV DNA levels < 300 copies/mL [24 week]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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]