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(+)

Bukwang Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

HBeAg(+) Chronic Hepatitis B

Treatments

Drug: Clevudine

Drug: Clevudine + Peg-interferon

Study type

Interventional

Funder types

Industry

Identifiers

NCT01264367

CMC-403

Details and patient eligibility

About

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(+)

Enrollment

60 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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]