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(+)

This study is currently recruiting participants.
Verified July 2012 by Bukwang Pharmaceutical
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01264367
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012

December 19, 2010
July 24, 2012
December 2008
February 2013   (final data collection date for primary outcome measure)
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR [ Time Frame: At week 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01264367 on ClinicalTrials.gov Archive Site
  • antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR [ Time Frame: At week 72 ] [ Designated as safety issue: No ]
  • antiviral activity: The change of HBV DNA from the baseline [ Time Frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72 ] [ Designated as safety issue: No ]
  • ALT normalization rate [ Time Frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72 ] [ Designated as safety issue: No ]
  • Proportion sustained complete response of patients with complete response [ Time Frame: At week 72 ] [ Designated as safety issue: No ]
  • Immunological endpoints [ Time Frame: Day1(predose), at week 24, 48, 72 ] [ Designated as safety issue: No ]
  • Proportion of patients with HBeAg loss/ HBeAg seroconversion [ Time Frame: At week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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(+)

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(+)

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HBeAg(+) Chronic Hepatitis B
  • Drug: Clevudine
    30mg,QD
    Other Name: Levovir
  • Drug: Clevudine + Peg-interferon
    30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
    Other Name: Levovir + Pagasys
  • Experimental: 1
    Clevudine 30mg
    Intervention: Drug: Clevudine
  • Active Comparator: 2
    Clevudine 30mg + peg-interferon 180mcg
    Intervention: Drug: Clevudine + Peg-interferon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
February 2013   (final data collection date for primary outcome measure)

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]
Both
18 Years to 60 Years
No
Contact: Lee Chang Don, MD. PhD +82-31-820-3000
Korea, Republic of
 
NCT01264367
CMC-403, CMC-403
No
Bukwang Pharm.CO.,LTD
Bukwang Pharmaceutical
Not Provided
Principal Investigator: Lee Chang Don, MD, PhD The catholic university of korea, Uijeongbu ST.Mary's hospital
Bukwang Pharmaceutical
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP