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

Bukwang Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Clevudine 30mg; Drug: Clevudine 20mg; Drug: Clevudine 20mg+Adefovir dipivoxil 10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01264354

CLV-412

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

1

Experimental group

Description:

Clevudine 30mg

Treatment:

Drug: Clevudine 30mg

2

Experimental group

Description:

Clevudine 20mg+Adefovir dipivoxil 10mg

Treatment:

Drug: Clevudine 20mg+Adefovir dipivoxil 10mg

3

Experimental group

Description:

Clevudine 20mg

Treatment:

Drug: Clevudine 20mg