Clinical trial NCT00442572: 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).
Official title: Stop Progression of Fibrosis by Administration of Intermittent Continuous Treatment With Peginterferon Alfa-2a. Open-label, Randomized Efficacy and Safety Clinical Trial of Intermittent Continuous Treatment With Peginterferon Alfa-2a (PEGASYS) in Patients With HBeAg Negative Hepatitis B Responding to Prior Treatment With Interferon Alfa (SOFIA -LTT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Percentage of Participants With Stable Virological Response
timeFrame: Up to Week 108
Secondary outcomes:
measure: Percentage of Participants With Stable Virological and Biochemical Response
timeFrame: Up to Week 108
measure: Percentage of Participants With Loss of Hepatitis B Surface Antigen
timeFrame: Up to Week 108
measure: Percentage of Participants With HBsAg Seroconversion
timeFrame: Up to Week 108
measure: Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity
timeFrame: Up to Week 108
measure: Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis
timeFrame: Up to Week 108
measure: Mean Change From Baseline in HBsAg Levels
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Hemoglobin
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Hematology
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Clinical Chemistry
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Protein and Indirect Albumin
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Blood Urea
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Creatinine and Uric Acid
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Blood Glucose
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)
timeFrame: Up to Week 108
measure: Mean Change From Baseline in Triiodothyronine and Thyroxine
timeFrame: Up to Week 108
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Mhat St. Ivan Rilski; Clinic of Gastroenterology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: