A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

NCT00641082 | Completed Phase 4

• 1 other identifier: CLV-401
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.

Conditions

HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with HBV DNA below 300copies/mL

  at week 48

Secondary Outcomes (4)

• The change of HBV DNA from the baseline

  at week 24, 48

• Proportion of patients with HBV DNA below LOD of RT-PCR

  at week 24, 48

• ALT normalization rate

  at week 24, 48

• Proportion of patients with viral breakthrough during 48-week treatment period

  at week 24, 48

Study Arms (2)

1

EXPERIMENTAL

Clevudine

Drug: Clevudine

2

ACTIVE COMPARATOR

Adefovir

Drug: Adefovir dipivoxil

Interventions

Clevudine DRUG

30mg for 48 weeks

Also known as: Levovir

1

Adefovir dipivoxil DRUG

10mg for 48 weeks

Also known as: Hepsera

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient is between 18 and 60
• Patient is documented to be HBsAg positive for \> 6 months.
• Patient with compensated hepatic function.
• Nucleoside treatment-naÃ-ve subjects of either gender
• Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(5) copies/mL within 30 days of baseline.
• Patient has ALT levels which are in the range of 2 x ULN and \< 10 X ULN
• Patient who has not a history of ascites, variceal hemorrhage or hepatic encephalopathy.

You may not qualify if:

• Patient is currently receiving antiviral or corticosteroid therapy.
• Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, 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.
• Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
• 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.
• Patient is coinfected with HCV, HDV or HIV.
• Patient with following clinical evidence
• Decompensated liver cirrhosis (Child class B,C: CPT score 7) or hepatocellular carcinoma
• Significant gastrointestinal, renal, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease
• Previous organ transplantation
• Patient has a clinically relevant history of abuse of alcohol or drugs.
• 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.
• Patient has α-Fetoprotein more than 100ng/mL
• Patient has Hemoglobin \<11g/dL (Male), 10g/dL (Female) or WBC count \< 3,500/mm3 (PMN\<1,500/mm3) or Platelet count \<50,000/mm3

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (2)

Seoul National University Bundang Hospital

Bundang, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

clevudine; adefovir dipivoxil

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2008
• First Posted: March 21, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2012
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

KR (2)