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(+)

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 Overview

• Status: Completed
• Conditions: HBeAg(+) Chronic Hepatitis B
• Intervention / Treatment: Drug: Clevudine; Drug: Clevudine + Peg-interferon

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical
• Investigators: Principal Investigator: Lee Chang Don, MD, PhD, The catholic university of korea, Uijeongbu ST.Mary's hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: December 19, 2010
• First Submitted That Met QC Criteria: December 19, 2010
• First Posted (ESTIMATE): December 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2014
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Clevudine
• Other Study ID Numbers: CMC-403