A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Bukwang Pharmaceutical
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01266005
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: Clevudine Drug: Entecavir |
Phase 4 |
| 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 Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients |
Resource links provided by NLM:
Further study details as provided by Bukwang Pharmaceutical:
Primary Outcome Measures:
- Intrahepatic cccDNA reduction from baseline [ Time Frame: week 48 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients with HBV DNA below LOD by real-time PCR [ Time Frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) ] [ Designated as safety issue: No ]
- Reduction of HBV DNA level from baseline [ Time Frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) ] [ Designated as safety issue: No ]
- ALT normalization [ Time Frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) ] [ Designated as safety issue: No ]
- Reduction of sAg titer from baseline [ Time Frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) ] [ Designated as safety issue: No ]
- Proportion of maintaining sustained effect [ Time Frame: every 8 weeks during follow-up period(48weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 75 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Clevudine 30mg
|
Drug: Clevudine
30mg,QD
Other Name: Levovir
|
|
Active Comparator: 2
Entecavir 0.5mg
|
Drug: Entecavir
0.5mg QD
Other Name: Baraclude
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient who is older than 18.
- Patient who is HBsAg positive for the previous 6 months and with HBV DNA ≥ 1 x 10^5 copies/mL
- Patient who is HBeAg negative.
- Patient with ALT≥1×ULN.
- 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.
- Patient is treated with interferon for the previous 6 months.
- Patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
- Patient is coinfected with HCV, HDV or HIV.
- Patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy.
- Patient has evidence of decompensated Liver cirrhosis and/or hepatocellular carcinoma.
- Patient has a history of organ transplantation.
- Patient has the treatment of nephrotoxicity drugs, competitive drugs for kidney to excrete, and/or hepatotoxicity drugs for the previous 2 months from screening.
- Patient is pregnant or breast-feeding.
- 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, allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
- 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: | Bukwang, Bukwang Pharm.Co.,LTD |
| ClinicalTrials.gov Identifier: | NCT01266005 History of Changes |
| Other Study ID Numbers: | CLV-410 |
| Study First Received: | December 19, 2010 |
| Last Updated: | July 24, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Bukwang Pharmaceutical:
|
HBe Ag(-) Chronic Hepatitis B |
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 Entecavir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013