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(+)

NCT01264367 | Completed Phase 4

• 1 other identifier: CMC-403
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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(+)

Conditions

HBeAg(+) Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

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

  At week 48

Secondary Outcomes (6)

• 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

Study Arms (2)

1

EXPERIMENTAL

Clevudine 30mg

Drug: Clevudine

2

ACTIVE COMPARATOR

Clevudine 30mg + peg-interferon 180mcg

Drug: Clevudine + Peg-interferon

Interventions

Clevudine DRUG

30mg,QD

Also known as: Levovir

1

Clevudine + Peg-interferon DRUG

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

Also known as: Levovir + Pagasys

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Uijeongbu St.Mary's Hospital

Uijeongbu-si, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

clevudine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lee Chang Don, MD, PhD

  The catholic university of korea, Uijeongbu ST.Mary's hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2010
• First Posted: December 21, 2010
• Study Start: December 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: May 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2012-07

Locations

KR (1)