Long-term Study With Clevudine
This study has been completed.
Sponsor:
Bukwang Pharmaceutical
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00558818
First received: November 14, 2007
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: Clevudine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase lV Study to Evaluate the Long-term Safety and Efficacy of Clevudine in the Patients Chronically Infected With Hepatitis B Virus |
Resource links provided by NLM:
Further study details as provided by Bukwang Pharmaceutical:
Primary Outcome Measures:
- Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR [ Time Frame: Screening, day1,every 12 weeks during treatment period(96weeks) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation [ Time Frame: Screening, day1, every 12 weeks during treatment period(96 weeks) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Clevudine
clevudine 30 mg qd
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Patient with DNA levels >=1 x 10^5 copies/mL within 30 days of baseline.
- Patient is documented to be HBsAg positive for > 6 months.
- Patient has ALT levels >=80 IU/L
- Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.
Exclusion Criteria.
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon within the previous 6 months.
- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
- 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 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: | hunjun jang, Bukwang Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00558818 History of Changes |
| Other Study ID Numbers: | KOR-404, KOR-404 |
| Study First Received: | November 14, 2007 |
| Last Updated: | July 24, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections 2'-fluoro-5-methylarabinosyluracil Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013