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. (see Contacts and Locations)
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
  Purpose

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(+)


Condition Intervention Phase
HBeAg(+) Chronic Hepatitis B
Drug: Clevudine
Drug: Clevudine + Peg-interferon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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(+)

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Clevudine 30mg
Drug: Clevudine
30mg,QD
Other Name: Levovir
Active Comparator: 2
Clevudine 30mg + peg-interferon 180mcg
Drug: Clevudine + Peg-interferon
30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
Other Name: Levovir + Pagasys

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264367

Contacts
Contact: Lee Chang Don, MD. PhD +82-31-820-3000

Locations
Korea, Republic of
Uijeongbu St.Mary's Hospital Recruiting
Uijeongbu, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
Principal Investigator: Lee Chang Don, MD, PhD The catholic university of korea, Uijeongbu ST.Mary's hospital
  More Information

No publications provided

Responsible Party: Bukwang Pharm.CO.,LTD
ClinicalTrials.gov Identifier: NCT01264367     History of Changes
Other Study ID Numbers: CMC-403, CMC-403
Study First Received: December 19, 2010
Last Updated: July 24, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Clevudine
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014