A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+)
NCT ID: NCT01264367
Last Updated: 2014-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2008-12-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Clevudine 30mg
Clevudine
30mg,QD
2
Clevudine 30mg + peg-interferon 180mcg
Clevudine + Peg-interferon
30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
Interventions
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Clevudine
30mg,QD
Clevudine + Peg-interferon
30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is HBV DNA positive with DNA levels ≥ 5 x 10\^5 copies/mL within 30 days of baseline.
3. Patient is documented to be HBsAg positive for \> 6 months and Patient is HBeAg positive.
4. Patient has ALT levels \>=80IU/L, prothrombin time(INR)\<1.7 and a serum albumin level of at least 3.5 g/dL.
5. Patient has hemoglobin levels \>=11.5g/dl(if woman) or \>=12.5g/dl(if man)
6. Women of childbearing potential must have a negative urine pregnancy test(β-HCG) taken within 14 days of starting therapy.
7. Patient is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria
2. Patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for HBV infection.
3. Patient is coinfected with HCV or HIV.
4. Patient with clinical evidence of decompensated liver disease or HCC
5. Patient has WBC levels \< 3.0x10\^9/L
6. Patient has Platelets levels \< 90x10\^9/L
7. Patient has alpha fetoprotein levels \> 100ng/mL
8. Patient has a history of Thyroid disease.
9. Patient has a history of autoimmune hepatitis.
10. Patient is pregnant or breast-feeding.
11. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
12. Patient has a clinically relevant history of abuse of alcohol or drugs.
13. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic or 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.
14. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
18 Years
60 Years
ALL
No
Sponsors
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Bukwang Pharmaceutical
INDUSTRY
Responsible Party
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Bukwang Pharm.CO.,LTD
Principal Investigators
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Lee Chang Don, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The catholic university of korea, Uijeongbu ST.Mary's hospital
Locations
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Uijeongbu St.Mary's Hospital
Uijeongbu-si, , South Korea
Countries
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Other Identifiers
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CMC-403
Identifier Type: -
Identifier Source: secondary_id
CMC-403
Identifier Type: -
Identifier Source: org_study_id