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CompletedNCT00362635Updated Jul 26, 2012

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

A Phase 3 interventional study of Clevudine in Hepatitis B, sponsored by Bukwang Pharmaceutical. Completed at 2 sites in Hong Kong. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-07-26.

Sponsored by Bukwang Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatitis B
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's planned enrollment of 92 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Bukwang Pharmaceutical is the lead sponsor of 34 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
92 participants (estimated)

Interventions

  • DrugClevudine
06

What researchers measure

Primary outcomes

  1. Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR

  2. Safety: Laboratory tests, Adverse Events, Physical examination

Secondary outcomes

  1. Efficacy:

  2. Viral kinetics of HBV DNA suppression

  3. Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.

  4. Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period

  5. 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

07

Study locations

2 sites
  • Alice Ho Miu Ling Nethersole Hospital
    Tai Po, New Territories, Hong Kong
  • Queen Mary Hospital
    Road, Hong Kong
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00362635
Lead sponsor
Bukwang Pharmaceutical
First posted
Aug 10, 2006
Start date
Aug 2006
Primary completion
Dec 2011
Last update
Jul 26, 2012

Study contacts

George KK Lau, M.D.
principal investigator · Queen Mary Hospital, Hong Kong
Nancy Leung, M.D.
principal investigator · Alice Ho Miu Ling Nethersole Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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