Phase 2
N=76
A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01706575 ↗Enrolled (actual)
76
Serious AEs
7.2%
Results posted
Aug 2016
Primary outcome: Primary: Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48) — 59.13 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pegylated Interferon (Peginterferon) Alfa-2a (Drug); Nucleos(t)ide Analogues (NA) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48) |
59.13 | — |
| PRIMARY Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48) |
67.44 | — |
| SECONDARY Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96 |
0; -546.32; -815.69; -728.16 | — |
| SECONDARY Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48 |
13.95 | — |
| SECONDARY Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96 |
1 | — |
| SECONDARY Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes |
— | — |
| SECONDARY Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels |
— | — |
| SECONDARY Safety: Percentage of Participants With Adverse Events (AE) |
92.75 | — |
Summary
This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.
Eligibility Criteria
Inclusion Criteria
- Adult participants, 18 - 65 years of age
- Chronic hepatitis B
- Negative for HBeAg
- On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months
- HBsAg >100 IU/ml at the beginning of the Lead-in phase, confirmed before addition of Pegasys
- Showing a steady HBsAg kinetic (HBsAg decrease /=6)
- History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
- Known hypersensitivity to peginterferon alfa-2a
- Pregnant of breastfeeding women
- Evidence of alcohol and/or drug abuse
- History of severe psychiatric disease, especially depression
- History of immunologically mediated disease
- History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- History or evidence of severe pulmonary disease associated with functional limitations
- History of severe cardiac disease
- History of severe seizure disorder or current anticonvulsant use
- Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study entry
- History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory (including systemic corticosteroids) treatment </= 6 months prior to the first dose or the expectation that such a treatment will be needed at any time during the study
- History or other evidence of severe retinopathy
Data sourced from ClinicalTrials.gov (NCT01706575). 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.