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(+)

Sponsor

Bukwang Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT01264367

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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(+)

Condition or Disease	Intervention/Treatment	Phase
HBeAg(+) Chronic Hepatitis B	Drug: Clevudine Drug: Clevudine + Peg-interferon	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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(+)

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Clevudine 30mg	Drug: Clevudine 30mg,QD Other Names: Levovir
Active Comparator: 2 Clevudine 30mg + peg-interferon 180mcg	Drug: Clevudine + Peg-interferon 30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks) Other Names: Levovir + Pagasys

Arm

Intervention/Treatment

Experimental: 1

Clevudine 30mg

Drug: Clevudine

30mg,QD

Other Names:

Levovir

Active Comparator: 2

Clevudine 30mg + peg-interferon 180mcg

Drug: Clevudine + Peg-interferon

30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)

Other Names:

Levovir + Pagasys

Outcome Measures

Primary Outcome Measures

antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR [At week 48]

Secondary Outcome Measures

antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR [At week 72]
antiviral activity: The change of HBV DNA from the baseline [Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72]
ALT normalization rate [Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72]
Proportion sustained complete response of patients with complete response [At week 72]
Immunological endpoints [Day1(predose), at week 24, 48, 72]
Proportion of patients with HBeAg loss/ HBeAg seroconversion [At week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is between 18~60 years
Patient is HBV DNA positive with DNA levels ≥ 5 x 10^5 copies/mL within 30 days of baseline.
Patient is documented to be HBsAg positive for > 6 months and Patient is HBeAg positive.
Patient has ALT levels >=80IU/L, prothrombin time(INR)<1.7 and a serum albumin level of at least 3.5 g/dL.
Patient has hemoglobin levels >=11.5g/dl(if woman) or >=12.5g/dl(if man)
Women of childbearing potential must have a negative urine pregnancy test(β-HCG) taken within 14 days of starting therapy.
Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
Patients previously treated with interferon, peg-interferon, clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for HBV infection.
Patient is coinfected with HCV or HIV.
Patient with clinical evidence of decompensated liver disease or HCC
Patient has WBC levels < 3.0x10^9/L
Patient has Platelets levels < 90x10^9/L
Patient has alpha fetoprotein levels > 100ng/mL
Patient has a history of Thyroid disease.
Patient has a history of autoimmune hepatitis.
Patient is pregnant or breast-feeding.
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.
Patient has a clinically relevant history of abuse of alcohol or drugs.
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.
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]