Phase 4
N=18
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00487747 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL — 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- peginterferon alfa-2a [Pegasys] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL |
4 | — |
| PRIMARY Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL |
3 | — |
| SECONDARY Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion |
4; 0; 4; 4 | — |
| SECONDARY Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT |
3; 2; 3 | — |
| SECONDARY Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) |
3; 0 | — |
| SECONDARY Mean Change in Laboratory Parameters (ALT Levels) |
92.9; 97.2; 109.4; 81.2; 65.1; 53.3 | — |
Summary
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-70 years of age;
- chronic hepatitis B;
- Hepatitis B Virus (HBV) DNA >100, 000 copies/mL.
Exclusion Criteria
- previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
- evidence of decompensated liver disease;
- history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
- coinfection with hepatitis A, C or D, or HIV.
Data sourced from ClinicalTrials.gov (NCT00487747). 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.