This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is \<50.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Ankara University Medical Facility; Hepatology Department
Ankara, Turkey (Türkiye)
Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
Bursa, Turkey (Türkiye)
Dicle Uni Medical Faculty; Gastroenterology
Diyarbakır, Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
Istanbul, Turkey (Türkiye)
proportion of patients becoming HDV-RNA negative
Time frame: week 96
HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology
Time frame: weeks 48, 96 and after 24 weeks of follow-up
Safety and tolerability: adverse events, laboratory parameters, vital signs
Time frame: throughout 96 weeks of treatment
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Ege Uni Medical Faculty Izmir; Gastroenterology
Izmir, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty; Infection
Izmir, Turkey (Türkiye)