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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01266005
• Other study ID #: CLV-410
• Status: Terminated
• Phase: Phase 4
• First received: December 19, 2010
• Last updated: December 16, 2014
• Start date: August 2009
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: January 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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]

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Clevudine
30mg,QD
• Entecavir
0.5mg QD

Locations

Country	Name	City	State
Korea, Republic of	9 Sites	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrahepatic cccDNA reduction from baseline		week 48	No
Secondary	Proportion of patients with HBV DNA below LOD by real-time PCR		day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)	No
Secondary	Reduction of HBV DNA level from baseline		day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)	No
Secondary	ALT normalization		day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)	No
Secondary	Reduction of sAg titer from baseline		day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)	No
Secondary	Proportion of maintaining sustained effect		every 8 weeks during follow-up period(48weeks)	No