Phase 3
N=48
Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
Hepatitis D, Chronic · Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00686790 ↗Enrolled (actual)
48
Serious AEs
6.1%
Results posted
Jan 2011
Primary outcome: Primary: Number of Participants With a Virological Response — 12; 24; 9; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Peginterferon alfa-2b (PegIntron, SCH 54031) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Virological Response |
12; 24; 9; 27 | — |
| PRIMARY Number of Participants With a Biochemical Response |
18; 14; 9; 23 | — |
| PRIMARY Number of Participants With a Combined Response |
7; 25; 6; 26 | — |
| SECONDARY Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response) |
6; 30 | — |
| SECONDARY Number of Participants With a Liver Histology Response |
10; 14; 6; 3; 3 | — |
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 65.
- Concomitant HCV and/or HIV infection.
- Actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time >3 sec, serum albumin 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.
Data sourced from ClinicalTrials.gov (NCT00686790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.