Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00362635
First received: August 8, 2006
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.


Condition Intervention Phase
Hepatitis B
Drug: Clevudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-blinded and Randomised Study to Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30 mg qd Versus Lamivudine 100 mg qd for Chronic Hepatitis B Infection

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
  • Safety: Laboratory tests, Adverse Events, Physical examination

Secondary Outcome Measures:
  • Efficacy:
  • Viral kinetics of HBV DNA suppression
  • Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.
  • Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period
  • Evaluation of the proportion of patients with HBV DNA <300 copies/ml, median HBV DNA change from baseline(log10 copies/ml), the proportion of patients with normal ALT, and HBV serology over an additional 48 weeks of open label treatment

Estimated Enrollment: 92
Study Start Date: August 2006
Primary Completion Date: December 2011 (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, inclusive.
  2. Patient is HBV DNA positive with DNA levels at screening >= 3 x 1,000,000 copies/mL.
  3. Patient is documented to be HBsAg positive for > 6 months and HBeAg positive.
  4. Patient has AST and ALT levels which are >= 1 times and <= 10 times the upper limit of normal (x ULN).
  5. Patient has bilirubin levels <= 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.
  6. Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment.
  7. 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 or corticosteroid therapy.
  2. Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection.
  3. Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  4. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patient is co-infected with HCV or HIV.
  6. Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
  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. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with spermicide or abstinence).
  9. Patient has a clinically relevant history of abuse of alcohol or drugs.
  10. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
  11. Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to Screening Visit.
  12. Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to Screening Visit.
  13. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
  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: NCT00362635

Locations
Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, New Territories, Hong Kong
Queen Mary Hospital
Road, Hong Kong
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
Principal Investigator: George KK Lau, M.D. Queen Mary Hospital, Hong Kong
Principal Investigator: Nancy Leung, M.D. Alice Ho Miu Ling Nethersole Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00362635     History of Changes
Other Study ID Numbers: CLV-310
Study First Received: August 8, 2006
Last Updated: July 24, 2012
Health Authority: Hong Kong: Department of Health

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

ClinicalTrials.gov processed this record on September 16, 2014