NCT00362635

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

Enrollment Period

5.3 years

First QC Date

August 8, 2006

Last Update Submit

July 24, 2012

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (2)

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

  • Safety: Laboratory tests, Adverse Events, Physical examination

Secondary Outcomes (5)

  • 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

Interventions

ClevudineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient is between 18 and 60, inclusive.
  • Patient is HBV DNA positive with DNA levels at screening \>= 3 x 1,000,000 copies/mL.
  • Patient is documented to be HBsAg positive for \> 6 months and HBeAg positive.
  • Patient has AST and ALT levels which are \>= 1 times and \<= 10 times the upper limit of normal (x ULN).
  • 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.
  • Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment.
  • Patient is able to give written informed consent prior to study start and to comply with the study requirements.

You may not qualify if:

  • Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  • Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection.
  • Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  • Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  • Patient is co-infected with HCV or HIV.
  • Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
  • Patient is pregnant or breast-feeding.
  • 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).
  • Patient has a clinically relevant history of abuse of alcohol or drugs.
  • Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
  • 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.
  • 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.
  • Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alice Ho Miu Ling Nethersole Hospital

Tai Po, New Territories, Hong Kong

Location

Queen Mary Hospital

Road, Hong Kong

Location

Related Links

MeSH Terms

Conditions

Hepatitis B

Interventions

clevudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • George KK Lau, M.D.

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

  • Nancy Leung, M.D.

    Alice Ho Miu Ling Nethersole Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 10, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2011

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

HK(2)