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).

Browse trials for

• Hepatitis A 2,709
• Hepatitis B 1,656
• Hepatitis B, Chronic 942
• Hepatitis 3,380

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 21 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Experimental
  PEGASYS

  Participants received 4 treatment cycles of continuous intermittent treatment with PEGASYS® (Peginterferon alfa-2a) . Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.

  Drug: PEGASYS [peginterferon alfa-2a]

• No intervention
  No Intervention

  Participants were on non- specific anti-viral treatment.

Interventions

• DrugPEGASYS [peginterferon alfa-2a]

  There were 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.

Primary outcomes

1. Percentage of Participants With Stable Virological Response

   Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) \<20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).

   Time frame: Up to Week 108

Secondary outcomes

1. Percentage of Participants With Stable Virological and Biochemical Response

   All participants who achieved virological response (serum HBV DNA \< 20 000 copies/ml) and biochemical response (stable normalization of their alanine transaminase \[ALT\]) during the treatment cycle (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).

   Time frame: Up to Week 108

2. Percentage of Participants With Loss of Hepatitis B Surface Antigen

   Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.

   Time frame: Up to Week 108

3. Percentage of Participants With HBsAg Seroconversion

   The development of antibodies against HBsAg is known as HBsAg seroconversion. It signifies clearance of HBsAg and resolution of the chronic infection. НBsAg seroconversion is the final goal of anti-hepatitis B virus treatment and it is closest to the definition of "cure" but in practice it is very rare in HBeAg-negative chronic hepatitis B (CHB).

   Time frame: Up to Week 108

4. Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity

   HBV DNA level, or viral load, is an indicator of viral replication. Higher HBV DNA levels are usually associated with an increased risk of liver disease and hepatocellular carcinoma. HBV DNA level typically falls in response to effective antiviral treatment.

   Time frame: Up to Week 108

5. Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis

   Fibrosis-4 (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) are non-invasive scoring systems, which are calculated on the basis of laboratory tests that indicates the level of liver fibrosis. The APRI scores are calculated based on Aspartate Aminotransferase (AST) levels and platelet counts whereas FIB-4 scores are calculated based on platelets, ALT, AST and age. For APRI, the scores are interpreted as ≤ 0.5 is 81% sensitive and 50% specific for a diagnosis of significant fibrosis in chronic hepatitis C (CHC), where as a cut-off \> 1.5 is 35% sensitive and 91% specific for the diagnosis of significant fibrosis. The majority of biomarker panels will produce inconclusive results for a proportion of participants falling within the indeterminate range (between 0.5 and 1.5) for a specific fibrosis end-point. For FIB-4, the scores are interpreted as FIB-4 score of \< 1.45: absence of cirrhosis, FIB-4 score of 1.45 to 3.25: inconclusive, FIB-4 score \> 3.25: cirrhosis.

   Time frame: Up to Week 108

6. Mean Change From Baseline in HBsAg Levels

   An early decrease in HBsAg from baseline to Weeks 12 or 24 has been identified as further on-treatment predictor for sustained HBsAg clearance and virological response in HBeAg negative participants.

   Time frame: Up to Week 108

7. Mean Change From Baseline in Hemoglobin

   The hemoglobin values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

   Time frame: Up to Week 108

8. Mean Change From Baseline in Hematology

   The hematology parameters included erythrocytes, leucocytes, basophils, eosinophils, lymphocytes, monocytes, thrombocytes. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

   Time frame: Up to Week 108

9. Mean Change From Baseline in Clinical Chemistry

   The clinical chemistry parameters included alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP). All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

   Time frame: Up to Week 108

10. Mean Change From Baseline in Protein and Indirect Albumin

    The clinical chemistry parameters included indirect protein and albumin. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and no intervention).

    Time frame: Up to Week 108

11. Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct

    The laboratory parameters included bilirubin indirect and bilirubin direct. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

    Time frame: Up to Week 108

12. Mean Change From Baseline in Blood Urea

    The blood urea was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

    Time frame: Up to Week 108

13. Mean Change From Baseline in Creatinine and Uric Acid

    The creatinine and uric acid values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

    Time frame: Up to Week 108

14. Mean Change From Baseline in Blood Glucose

    The blood glucose was measured for change from baseline. All blood glucose values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

    Time frame: Up to Week 108

15. Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)

    The TSH was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

    Time frame: Up to Week 108

16. Mean Change From Baseline in Triiodothyronine and Thyroxine

    The Triiodothyronine (T3) and thyroxine (T4) values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).

    Time frame: Up to Week 108

Baseline characteristics