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

• Sponsor: Bukwang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00501124
• Collaborator: (none)
• Enrollment: 70
• Locations: 7
• Patients Per Site: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Drug: Clevudine; Biological: Purified hepatitis B surface antigen	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2007
• Actual Primary Completion Date: Jul 1, 2010

Outcome Measures

Primary Outcome Measures

1. Antiviral Activity: Proportion of patients with HBeAg loss [Screening, Day1(predose), every 4 weeks during treatment period(48weeks)]

2. Safety Endpoints:Laboratory tests, Adverse Events, Vital signs, ECG [Screening, Day1(predose), every 4 weeks during treatment period(48weeks), ECG: screening, Week48]

Secondary Outcome Measures

1. 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)]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (β-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]

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Bukwang Pharmaceutical

Investigators

• Principal Investigator: Heon Young Lee, MD. PhD., Chungnam National University Hospital
• Principal Investigator: Hyeon Woong Yang, MD. PhD., Eulji University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00501124
• Other Study ID Numbers: L-FMAU-402
• First Posted: Jul 13, 2007
• Last Update Posted: Dec 22, 2010
• Last Verified: Aug 1, 2009

• Additional relevant MeSH terms: Hepatitis B; Clevudine

Study Results

No Results Posted as of Dec 22, 2010