A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

Phase 4

Terminated

• Conditions: Chronic Hepatitis B

• Registration Number: NCT01264133
• Lead Sponsor: Bukwang Pharmaceutical

Brief Summary

An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with chronic hepatitis B.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-12-19
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Primary Completion: 2013-06
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patient is 18 years and older.
2. Patient is documented to be HBsAg positive for > 6 months.
3. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
4. Patient has ALT levels >=80 IU/L
5. Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis <= 6)
6. 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. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
3. Patients previously treated 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 a history of ascites, variceal hemorrhage or hepatic encephalopathy.
6. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
7. Patient with previous liver transplantation
8. Patient is pregnant or breast-feeding.
9. Patient has a clinically relevant history of abuse of alcohol or drugs.
10. 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.
11. 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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Proportion of patients with HBV DNA levels < 60 IU/mL	48 week

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of