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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Bukwang Pharmaceutical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01266005
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
  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:

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266005

Locations
Korea, Republic of
9 Sites
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  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, 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014