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Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Clevudine

Purified hepatitis B surface antigen

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is between 18 and 60
Patient is HBV DNA positive with DNA levels ≥ 5 x 10(6) copies/mL within 30 days of baseline.
Patient is documented to be HBsAg positive for > 6 months. Patient is HBeAg positive.
Patient has ALT levels which are in the range of ≥2 x ULN/L at least 2 consecutive visits, at least one month apart and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
Patient 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, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Patient is coinfected with HCV, HDV or HIV.
Patient with clinical evidence of decompensated liver disease or HCC
ANA > 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis
Patient is pregnant or breast-feeding.
Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
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 or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
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]

Sites / Locations

Chungbuk National University Hospital
Dankook University Hospital
Soon Chun Hyang University Cheonan Hospital
The Catholic University of Korea, Daejeon St. Mary's Hospital
Chungnam National University Hospital
Eulji University Hospital
Konyang University Hospital

Outcomes

Primary Outcome Measures

Antiviral Activity: Proportion of patients with HBeAg loss

Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG

Secondary Outcome Measures

Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion

Immunological endpoints: Alterations in immunological parameters before, after therapy, particularly with regards to the proliferative a

Full Information

NCT ID

NCT00501124

First Posted

July 12, 2007

Last Updated

December 21, 2010

Sponsor

Bukwang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00501124

Brief Title

Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV

Official Title

Phase IV Study to Evaluate the Safety and Efficacy of Clevudine Compared With Clevudine and Vaccine in Patients Chronically Infected With HBV, HBeAg(+)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Bukwang Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Clevudine

Intervention Type

Biological

Intervention Name(s)

Purified hepatitis B surface antigen

Primary Outcome Measure Information:

Title

Antiviral Activity: Proportion of patients with HBeAg loss

Time Frame

Screening, Day1(predose), every 4 weeks during treatment period(48weeks)

Title

Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG

Time Frame

Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48

Secondary Outcome Measure Information:

Title

Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion

Time Frame

Screening, Day1(predose), every 4 weeks during treatment period(48weeks)

Title

Immunological endpoints: Alterations in immunological parameters before, after therapy, particularly with regards to the proliferative a

Time Frame

Day1(predose), Week 8, 16, 24, 28, 32, 40 and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is between 18 and 60 Patient is HBV DNA positive with DNA levels ≥ 5 x 10(6) copies/mL within 30 days of baseline. Patient is documented to be HBsAg positive for > 6 months. Patient is HBeAg positive. Patient has ALT levels which are in the range of ≥2 x ULN/L at least 2 consecutive visits, at least one month apart and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL. Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy. Patient 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, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient is coinfected with HCV, HDV or HIV. Patient with clinical evidence of decompensated liver disease or HCC ANA > 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis Patient is pregnant or breast-feeding. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. 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 or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor. 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]

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heon Young Lee, MD. PhD.

Organizational Affiliation

Chungnam National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hyeon Woong Yang, MD. PhD.

Organizational Affiliation

Eulji University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chungbuk National University Hospital

City

Gaesin-dong, Cheongju Si Heungdeok-gu

State/Province

Chungcheongbuk-Do

Country

Korea, Republic of

Facility Name

Dankook University Hospital

City

Anseo-dong, Cheonan Si

State/Province

Chungcheongnam-Do

Country

Korea, Republic of

Facility Name

Soon Chun Hyang University Cheonan Hospital

City

Bongmyeong-dong, Cheonan Si

State/Province

Chungcheongnam-Do

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Daejeon St. Mary's Hospital

City

Daeheung-dong, Jung-gu

State/Province

Daejeon

Country

Korea, Republic of

Facility Name

Chungnam National University Hospital

City

Daesa-dong, Jung-gu

State/Province

Daejeon

Country

Korea, Republic of

Facility Name

Eulji University Hospital

City

Dunsan 2-dong, Seo-gu

State/Province

Daejeon

Country

Korea, Republic of

Facility Name

Konyang University Hospital

City

Gasuwon-dong, Seo-gu,

State/Province

Daejeon

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV

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