Phase 4
Completed N=280
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT00922207 ↗
Enrolled (actual)
280
Serious AEs
9.4%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment — 27.4; 29.5; 36.3 percentage of participants — p=0.6853
Summary
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment |
27.4; 29.5; 36.3 | 0.6853 |
| SECONDARY Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 |
8.65; 8.30; 8.41; -2.15; -2.76; -0.23 | 0.0353 sig |
| SECONDARY Percentage of Participants Who Were HBeAg Negative |
3.3; 2.1; 0.0; 5.6; 4.3; 1.1 | 0.6107 |
| SECONDARY Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels |
4.4; 3.2; 2.1; 4.4; 5.4; 6.5 | 0.6921 |
| SECONDARY Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 |
3.97; 3.76; 3.84; -0.26; -0.18; -0.02 | 0.0649 |
| SECONDARY Percentage of Participants With Combined Response |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-65 years of age;
- HBeAg+ve for >=3 months;
- positive serum HBV DNA within 3 months prior to entry;
- patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
- >=3 months treatment-free interval from nucleotide analogues.
Exclusion Criteria
- evidence of decompensated liver disease;
- history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
- co-infection with active hepatitis A, C or D, or HIV.
Data sourced from ClinicalTrials.gov (NCT00922207). 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.