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OpenTrials
Completed

NCT Number: 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(+)

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(+)

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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]

Treatment and study plan

Clevudine

Drug

30mg,QD

Other names: Levovir

Clevudine + Peg-interferon

Drug

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

Other names: Levovir + Pagasys

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. antiviral activity: The change of HBV DNA from the baseline

    Time frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72

  3. ALT normalization rate

    Time frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72

  4. Proportion sustained complete response of patients with complete response

    Time frame: At week 72

  5. Immunological endpoints

    Time frame: Day1(predose), at week 24, 48, 72

  6. Proportion of patients with HBeAg loss/ HBeAg seroconversion

    Time frame: At week 48

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Dec 21, 2010
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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