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A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01266005
First Posted: December 24, 2010
Last Update Posted: December 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bukwang Pharmaceutical
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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) ]
  • 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) ]
  • ALT normalization [ Time Frame: day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks) ]
  • 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) ]
  • Proportion of maintaining sustained effect [ Time Frame: every 8 weeks during follow-up period(48weeks) ]

Estimated Enrollment: 75
Study Start Date: August 2009
Study Completion Date: January 2014
Primary Completion Date: August 2013 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient who is older than 18.
  2. Patient who is HBsAg positive for the previous 6 months and with HBV DNA ≥ 1 x 10^5 copies/mL
  3. Patient who is HBeAg negative.
  4. Patient with ALT≥1×ULN.
  5. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
  2. Patient is treated with interferon for the previous 6 months.
  3. Patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
  4. Patient is coinfected with HCV, HDV or HIV.
  5. Patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy.
  6. Patient has evidence of decompensated Liver cirrhosis and/or hepatocellular carcinoma.
  7. Patient has a history of organ transplantation.
  8. Patient has the treatment of nephrotoxicity drugs, competitive drugs for kidney to excrete, and/or hepatotoxicity drugs for the previous 2 months from screening.
  9. Patient is pregnant or breast-feeding.
  10. Patient has a clinically relevant history of abuse of alcohol or drugs.
  11. 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.
  12. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266005


Locations
Korea, Republic of
9 Sites
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

Responsible Party: Bukwang, Bukwang Pharm.Co.,LTD
ClinicalTrials.gov Identifier: NCT01266005     History of Changes
Other Study ID Numbers: CLV-410
First Submitted: December 19, 2010
First Posted: December 24, 2010
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Bukwang Pharmaceutical:
HBe Ag(-) Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Entecavir
Clevudine
Antiviral Agents
Anti-Infective Agents