Phase 4
N=383
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00927082 ↗Enrolled (actual)
383
Serious AEs
6.5%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. — 9.7; 14.6; 19.8; 31.6 Percentage of 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
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. |
9.7; 14.6; 19.8; 31.6; 20.4; 31.5 | — |
| PRIMARY Percentage of Participants With HBsAg Loss |
0.0; 1.1; 1.9; 3.2; 1.1; 0.0 | — |
| SECONDARY Percentage of Participants With HBeAg Loss. |
9.7; 14.6; 19.8; 33.7; 23.7; 31.5 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion. |
0.0; 1.1; 1.9; 3.2; 1.1; 0.0 | — |
| SECONDARY Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe). |
23.7; 27.0; 29.2; 40.0; 28.0; 42.7 | — |
| SECONDARY Percentage of Participants With Presence of Anti-HBs |
4.3; 2.2; 11.3; 9.5; 6.5; 3.4 | — |
| SECONDARY Percentage of Participants With Normalised Alanine Transaminase (ALT) |
28.0; 27.0; 38.7; 49.5; 45.2; 44.9 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL). |
22.6; 33.7; 34.0; 50.5; 33.3; 31.5 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL) |
15.1; 21.3; 27.4; 45.3; 20.4; 23.6 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL) |
5.4; 12.4; 16.0; 32.6; 12.9; 7.9 | — |
| SECONDARY Quantitative HBsAg |
3.541; 3.371; 3.322; 2.949; 3.495; 3.484 | — |
| SECONDARY Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B |
49; 40; 51; 36; 9; 7 | — |
| SECONDARY Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB) |
3; 5; 9; 5; 89; 83 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
66; 67; 74; 56; 60; 60 | — |
Summary
This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- Informed consent for Study WV19432
- Patients who have completed treatment and follow-up on study WV19432
Exclusion Criteria
- As for Study WV19432
Data sourced from ClinicalTrials.gov (NCT00927082). 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.