Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)

Condition(s) targeted: Hepatitis D, Chronic; Hepatitis B, Chronic

Intervention: Peginterferon alfa-2b (PegIntron, SCH 54031) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Official title: An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants With a Virological Response

Number of Participants With a Biochemical Response

Number of Participants With a Combined Response

Secondary outcome:

Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)

Number of Participants With a Liver Histology Response

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Starting date: December 2005
Last updated: October 20, 2014