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

Hepatitis B Clinical Trial

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(+)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501124
• Other study ID #: L-FMAU-402
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2007
• Last updated: December 21, 2010
• Start date: May 2007

Study information

• Verified date: August 2009
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patient is between 18 and 60

2. Patient is HBV DNA positive with DNA levels = 5 x 10(6) copies/mL within 30 days of baseline.

3. Patient is documented to be HBsAg positive for > 6 months. Patient is HBeAg positive.

4. 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.

5. Women of childbearing potential must have a negative urine (ß-HCG) pregnancy test taken within 14 days of starting therapy.

6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.

2. Patients previously treated with interferon, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.

3. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.

4. Patient is coinfected with HCV, HDV or HIV.

5. Patient with clinical evidence of decompensated liver disease or HCC

6. ANA > 1:160 and positive anti-smooth muscle antibody as evidence of autoimmune hepatitis

7. Patient is pregnant or breast-feeding.

8. 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.

9. Patient has a clinically relevant history of abuse of alcohol or drugs.

10. 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.

11. 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• Clevudine

Biological:
• Purified hepatitis B surface antigen

Locations

Country	Name	City	State
Korea, Republic of	Dankook University Hospital	Anseo-dong, Cheonan Si	Chungcheongnam-Do
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Bongmyeong-dong, Cheonan Si	Chungcheongnam-Do
Korea, Republic of	The Catholic University of Korea, Daejeon St. Mary's Hospital	Daeheung-dong, Jung-gu	Daejeon
Korea, Republic of	Chungnam National University Hospital	Daesa-dong, Jung-gu	Daejeon
Korea, Republic of	Eulji University Hospital	Dunsan 2-dong, Seo-gu	Daejeon
Korea, Republic of	Chungbuk National University Hospital	Gaesin-dong, Cheongju Si Heungdeok-gu	Chungcheongbuk-Do
Korea, Republic of	Konyang University Hospital	Gasuwon-dong, Seo-gu,	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiviral Activity: Proportion of patients with HBeAg loss		Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Primary	Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG		Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48
Secondary	Proportion of patients with HBV DNA below LOD, Biochemical improvement, Proportion of patients with seroconversion		Screening, Day1(predose), every 4 weeks during treatment period(48weeks)
Secondary	Immunological endpoints: Alterations in immunological parameters before, after therapy, particularly with regards to the proliferative a		Day1(predose), Week 8, 16, 24, 28, 32, 40 and 48