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

NCT ID: NCT01264354

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Clevudine 30mg

Group Type EXPERIMENTAL

Clevudine 30mg

Intervention Type DRUG

Clevudine 30mg

2

Clevudine 20mg+Adefovir dipivoxil 10mg

Group Type EXPERIMENTAL

Clevudine 20mg+Adefovir dipivoxil 10mg

Intervention Type DRUG

Clevudine 20mg+ Adefovir 10mg

3

Clevudine 20mg

Group Type EXPERIMENTAL

Clevudine 20mg

Intervention Type DRUG

Clevudine 20mg

Interventions

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Clevudine 30mg

Clevudine 30mg

Intervention Type DRUG

Clevudine 20mg+Adefovir dipivoxil 10mg

Clevudine 20mg+ Adefovir 10mg

Intervention Type DRUG

Clevudine 20mg

Clevudine 20mg

Intervention Type DRUG

Other Intervention Names

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Levovir 30mg Levovir 20mg+Adefovir 10mg Levovir 20mg

Eligibility Criteria

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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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bukwang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CLV-412

Identifier Type: -

Identifier Source: org_study_id