Phase 4
Completed N=551
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT00435825 ↗
Enrolled (actual)
551
Serious AEs
3.5%
Results posted
Jun 2013
Primary outcomePrimary: Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment — 14.08; 22.86; 25.76; 36.15 Percentage of participants
Summary
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment |
14.08; 22.86; 25.76; 36.15 | — |
| SECONDARY Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 |
18.31; 27.14; 25.76; 36.15 | — |
| SECONDARY Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment |
14.79; 22.86; 26.52; 36.15 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment |
0.0; 0.0; 1.52; 2.31 | — |
| SECONDARY Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment |
0.70; 0.0; 2.27; 2.31 | — |
| SECONDARY Percentage of Participants With Normal Alanine Aminotransferase (ALT) |
30.28; 30.71; 43.18; 52.31 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment |
21.83; 21.43; 32.58; 42.31 | — |
| SECONDARY Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment |
11.27; 11.43; 22.73; 30.0 | — |
| SECONDARY Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment |
7.75; 15.0; 17.42; 31.54 | — |
| SECONDARY Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment |
7.75; 9.29; 13.64; 24.62 | — |
| SECONDARY Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment |
1.90; 1.97; 1.90; 1.73 | — |
| SECONDARY Quantitative HBV-DNA 24 Weeks Following End of Treatment |
6.33; 6.38; 5.98; 5.29 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA >500,000 copies/mL, and anti-HBs negative;
- liver disease consistent with Chronic Hepatitis B.
Exclusion Criteria
- antiviral therapy for CHB within previous 6 months;
- co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV) or Human immuno deficiency virus (HIV);
- evidence of decompensated liver disease;
- medical condition associated with chronic liver disease.
Data sourced from ClinicalTrials.gov (NCT00435825). 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.