Phase 4
Completed N=197
A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT00940485 ↗
Enrolled (actual)
197
Serious AEs
3.1%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48 — 14.89; 6.12 Percentage of participants
Summary
This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48 |
14.89; 6.12 | — |
| SECONDARY Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48 |
62.77; 60.20 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48 |
62.77; 91.84 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48 |
8.51; 0 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48 |
4.26; 0 | — |
| SECONDARY Percentage of Participants With Normalized Alanine Aminotransferase at Week 48 |
51.06; 85.71 | — |
| SECONDARY Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time |
8.33; 5.66; 4.76; 5.85; 3.83; 5.00 | — |
| SECONDARY Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time |
3737.84; 3241.06; 3603.56; 3050.79; 3041.86; 3037.82 | — |
| SECONDARY Number of Participants With Incidence of Adverse Events and Serious Adverse Events |
65; 5; 6; 0; 67; 5 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event |
6; 0; 8; 0; 9; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >=18 and </= 65 years of age
- HBeAg positive chronic hepatitis B
- Pre-treatment with entecavir for 9-36 months
Exclusion Criteria
- Antiviral, antineoplastic or immunomodulatory treatment
- Co-infection with active hepatitis A, C or D, or HIV
- Evidence of decompensated liver disease
- History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
Data sourced from ClinicalTrials.gov (NCT00940485). 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. Informational only — not medical advice.