Phase 2
N=170
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT01524679 ↗Enrolled (actual)
170
Serious AEs
10.0%
Results posted
Feb 2020
Primary outcome: Primary: Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks — 26; 1; 80; 53 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pegylated interferon alfa-2a plus nucleos(t)ide(s) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johannes Gutenberg University Mainz
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks |
26; 1; 80; 53 | <0.0001 sig |
| SECONDARY Change in Quantitative HBs Antigen at Week 12 |
0.7058; 0.9380 | 0.0957 |
| SECONDARY Change in Quantitative HBs Antigen at Week 24 |
0.3694; 0.7995 | 0.0005 sig |
Summary
A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B
The primary objective of the trial is to investigate whether the add-on of pegylated interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48 weeks.
170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an oral antiviral regimen and having a nondetectable viral load for at least 12 months are included.
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis B, HBe antigen negative
- treatment with a stable oral antiviral treatment (not containing telbivudine) and a fully suppressed viral load for at least 12 months (below limit of detection in conventional HBV-PCR assays, i.e. <116 IU / ml).
- 18-70 ys
- willingness and ability to give informed consent and to follow study procedures
- willingness to use adequate contraception
Exclusion Criteria
- contraindications against treatment with pegylated interferon, e.g. depression, uncontrolled epilepsy, autoimmune diseases, pregnancy, leukocytopenia or thrombocytopenia at screening, etc.
- active alcohol or drug abuse
- preexisting polyneuropathy
Data sourced from ClinicalTrials.gov (NCT01524679). 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.