Phase 2
Completed N=21
SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT00442572 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants With Stable Virological Response — 100; 100.0; 52.9; 66.7 Percentage of Participants
Summary
This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with interferon alfa. After 48 weeks therapy with interferon alfa, and 24 weeks treatment-free follow-up, eligible patients will be randomized into the PEGASYS or the observational group. Those in the PEGASYS group will receive 4 therapeutic cycles of long term intermittent treatment with PEGASYS (135 micrograms sc weekly for 12 weeks, followed by a treatment-free period of 12 weeks) and those in the observational arm will receive no specific antiviral treatment. The anticipated time on study treatment is 1-2 years, and the target sample size is 100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Stable Virological Response |
100; 100.0; 52.9; 66.7; 52.9; 100.0 | — |
| SECONDARY Percentage of Participants With Stable Virological and Biochemical Response |
100.0; 100.0; 52.9; 66.7; 52.9; 100.0 | — |
| SECONDARY Percentage of Participants With Loss of Hepatitis B Surface Antigen |
5.9; 0 | — |
| SECONDARY Percentage of Participants With HBsAg Seroconversion |
— | — |
| SECONDARY Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity |
29.4 | — |
| SECONDARY Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis |
1.06; 0.25 | — |
| SECONDARY Mean Change From Baseline in HBsAg Levels |
-1156.00; -240.50; -1293.72; -146.00; -3049.64; -564.00 | — |
| SECONDARY Mean Change From Baseline in Hemoglobin |
-1.73 | — |
| SECONDARY Mean Change From Baseline in Hematology |
0.08; -1.72; -0.18; 5.56; 1.87; -31.20 | — |
| SECONDARY Mean Change From Baseline in Clinical Chemistry |
5.56; 9.00; 1.00; 50.92 | — |
| SECONDARY Mean Change From Baseline in Protein and Indirect Albumin |
-31.62; -1.35 | — |
| SECONDARY Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct |
-0.95; -0.16 | — |
| SECONDARY Mean Change From Baseline in Blood Urea |
-0.34 | — |
| SECONDARY Mean Change From Baseline in Creatinine and Uric Acid |
-3.65; -21.51 | — |
| SECONDARY Mean Change From Baseline in Blood Glucose |
-0.06 | — |
| SECONDARY Mean Change From Baseline in Thyroid Stimulating Hormone (TSH) |
0.67 | — |
| SECONDARY Mean Change From Baseline in Triiodothyronine and Thyroxine |
0.19; -0.85 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- liver disease consistent with CHB;
- evidence of chronic HBeAg-negative CHB prior to initial course of interferon alfa;
- patients who have responded to previous 48 weeks treatment with interferon alfa.
Exclusion Criteria
- coinfection with HCV, HDV or HIV;
- decompensated liver disease, hepatocellular cancer, or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
- any other systemic antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.
Data sourced from ClinicalTrials.gov (NCT00442572). 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.