Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
Condition: Hepatitis D, Chronic; Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Coinfection; Hepatitis D; Hepatitis D, Chronic; Hepatitis
Intervention: Peginterferon alfa-2b (PegIntron, SCH 54031)
Intervention description: Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.
Intervention MeSH terms: Peginterferon alfa-2b; Interferon-alpha
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis D; Hepatitis B

Summary:

      The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5
      mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected
      with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic,
      biochemical, and histological response will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must demonstrate their willingness to participate in the study and comply
             with its procedures by signing a written informed consent.

          -  Age 18-65 years old.

          -  HBsAg positive >6 months.

          -  ALT >= 2 ULN >6 months.

          -  HDV RNA positive serology.

          -  Serum antibody to hepatitis delta antigen of IgG and IgM class.

          -  Knodell score HAI >= 6 and F >= 0; positive test for intrahepatic Delta antigen in
             liver biopsy.

          -  Women of childbearing potential (includes women who are less than 1 year
             postmenopausal and women who become sexually active) must be using an acceptable
             method of birth control (e.g., hormonal contraceptive, medically prescribed IUD,
             condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy
             or tubal ligation).

          -  Participants must be free of any clinically significant disease (other than chronic
             hepatitis B and D), that would interfere with study evaluations.

          -  Participants must understand and be able to adhere to the dosing and visit schedules,
             and agree to record symptom severity scores, medication times, concomitant
             medications, and adverse events accurately and consistently in a daily diary.

        Exclusion Criteria:

          -  Age <18 and >65.

          -  Concomitant HCV and/or HIV infection.

          -  Actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time
             >3 sec, serum albumin <3 g/dl, history of ascites, variceal bleeding, or hepatic
             encephalopathy).

          -  Toxic or autoimmune hepatitis (ANA titers > 1:160), metabolic liver diseases (Wilson
             disease, hemochromatosis, α-1 antitrypsin deficiency)

          -  Women who are pregnant or nursing.

          -  Leukopenia (<2500/mm^3), neutropenia (<1000/mm^3), hemoglobin <10 g/dl, presence of
             other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension,
             neoplasia, neurologic diseases, malnutrition).

          -  Antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6
             months of the participation in the study.

          -  Depression and/or psychiatric disorders.