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

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

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Clevudine 30mg; Drug: Clevudine 20mg+Adefovir dipivoxil 10mg; Drug: Clevudine 20mg

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with HBV DNA levels < 300 copies/mL	24 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of HBV DNA form the baseline	(log copies/mL)	24week, 48week, 96week
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

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: December 19, 2010
• First Submitted That Met QC Criteria: December 19, 2010
• First Posted (ESTIMATE): December 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Adefovir; Adefovir dipivoxil; Clevudine
• Other Study ID Numbers: CLV-412