A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B
This study is ongoing, but not recruiting participants.
Sponsor:
Bukwang Pharmaceutical
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00672867
First received: May 2, 2008
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.
| Condition | Intervention | Phase |
|---|---|---|
|
Patients With LC-B |
Drug: Clevudine Drug: Adefovir dipivoxil |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Open Randomized Clinical Trial Comparing the Efficacy and Safety of Clevudine 30mg Versus Adefovir 10mg in Patients With LC-B |
Resource links provided by NLM:
Further study details as provided by Bukwang Pharmaceutical:
Primary Outcome Measures:
- Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The change of HBV DNA from the baseline. [ Designated as safety issue: No ]
- Child-Pugh score improvement [ Designated as safety issue: No ]
- MELD score improvement [ Designated as safety issue: No ]
- Biochemical improvement [ Designated as safety issue: No ]
- Proportion of patients with HBeAg loss and/or seroconversion [ Designated as safety issue: No ]
| Estimated Enrollment: | 102 |
| Study Start Date: | December 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Clevudine
|
Drug: Clevudine
30mg
Other Name: Levovir
|
|
Active Comparator: 2
Adefovir
|
Drug: Adefovir dipivoxil
10mg
Other Name: Hepsera
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is 18 years and older.
- 5 ≦ 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.
Exclusion Criteria:
- 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]
Contacts and Locations
More Information
No publications provided
| Responsible Party: | -- |
| ClinicalTrials.gov Identifier: | NCT00672867 History of Changes |
| Other Study ID Numbers: | L-FMAU-309 |
| Study First Received: | May 2, 2008 |
| Last Updated: | July 24, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
2'-fluoro-5-methylarabinosyluracil Adefovir Adefovir dipivoxil Antiviral Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on June 17, 2013