Clinical trial NCT01264367: 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(+)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HBeAg(+) Chronic Hepatitis B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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(+)


Eligibility criteria: Inclusion Criteria:

1. Patient is between 18\~60 years
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:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Primary outcomes:
measure: antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR
timeFrame: At week 48
Secondary outcomes:
measure: antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR
timeFrame: At week 72
measure: antiviral activity: The change of HBV DNA from the baseline
timeFrame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
measure: ALT normalization rate
timeFrame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
measure: Proportion sustained complete response of patients with complete response
timeFrame: At week 72
measure: Immunological endpoints
timeFrame: Day1(predose), at week 24, 48, 72
measure: Proportion of patients with HBeAg loss/ HBeAg seroconversion
timeFrame: At week 48
Other outcomes:
Locations:
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St.Mary's Hospital
Study officials:
affiliation: The catholic university of korea, Uijeongbu ST.Mary's hospital
name: Lee Chang Don, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: