A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B

NCT00672867 | Completed Phase 3

• 1 other identifier: L-FMAU-309
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.

Conditions

Patients With LC-B

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR

Secondary Outcomes (5)

• The change of HBV DNA from the baseline.

• Child-Pugh score improvement

• MELD score improvement

• Biochemical improvement

• Proportion of patients with HBeAg loss and/or seroconversion

Study Arms (2)

1

EXPERIMENTAL

Clevudine

Drug: Clevudine

2

ACTIVE COMPARATOR

Adefovir

Drug: Adefovir dipivoxil

Interventions

Clevudine DRUG

30mg

Also known as: Levovir

1

Adefovir dipivoxil DRUG

10mg

Also known as: Hepsera

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years and older.
• ≦ Child-Pugh score ≦ 12
• Patient is HBV DNA positive with DNA levels ≥ 1 x 10(4) copies/mL within 30 days of baseline.
• Patient is documented to be HBsAg positive for \> 6 months.
• Patient is HBeAg positive or negative.
• Patient has ALT or AST levels which are in the range of \> 1 x ULN and \< 15 X ULN
• Patient with liver cirrhosis diagnosed by imaging study within 1 year or clinical evidence of portal hypertension
• Life expectancy of at least 12 months
• Female patient with a negative urine(Beta-HCG) pregnancy test taken within 14 days of starting therapy.
• Patient who 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, cytotoxic or corticosteroid therapy.
• Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
• Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
• Patient is coinfected with HCV, HDV or HIV.
• Patient with clinical evidence of hepatocellular carcinoma
• Patient has alpha-fetoprotein \> 400ng/mL.
• Patient has Hemoglobin \<8g/dL (Male), 7.5g/dL (Female) or WBC \<1,500mm3 or Neutrophils \<500/mm3 or Platelet count \<30,000/mm3.
• 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 a clinically relevant history of abuse of alcohol or drugs.
• Patient with previous liver transplantation
• Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
• Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

clevudine; adefovir dipivoxil

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: December 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: September 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2012-07

Locations

KR (1)