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

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00501124
First received: July 12, 2007
Last updated: December 21, 2010
Last verified: August 2009
  Purpose

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 Intervention Phase
Hepatitis B
Drug: Clevudine
Biological: Purified hepatitis B surface antigen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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(+)

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Antiviral Activity: Proportion of patients with HBeAg loss [ Time Frame: Screening, Day1(predose), every 4 weeks during treatment period(48weeks) ]
  • 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 Measures:
  • 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) ]
  • 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 ]

Estimated Enrollment: 70
Study Start Date: May 2007
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501124

Locations
Korea, Republic of
Chungbuk National University Hospital
Gaesin-dong, Cheongju Si Heungdeok-gu, Chungcheongbuk-Do, 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
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
  More Information

No publications provided

Responsible Party: HY Lee, Chungnam University Hospital
ClinicalTrials.gov Identifier: NCT00501124     History of Changes
Other Study ID Numbers: L-FMAU-402
Study First Received: July 12, 2007
Last Updated: December 21, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Clevudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014