Hepatitis D, Chronic
Conditions
Brief summary
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.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
180mcg sc weekly, 96 weeks
DRUGplacebo
orally daily, 96 weeks
DRUGtenofovir
245mg po daily, 96 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>/=18 years of age * chronic hepatitis D * positive for HBsAg \>/=6 months, for anti-HDV \>/=3 months and for HDV-RNA at screening * negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study
Exclusion criteria
* antiviral therapy for chronic hepatitis D within the previous 6 months * previous therapy with pegylated interferon alfa * treatment with conventional interferon alfa for \>12 months * hepatitis A or C, or HIV infection * decompensated liver disease (Childs B-C) * history or evidence of medical condition associated with chronic liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients becoming HDV-RNA negative | week 96 |
Secondary
| Measure | Time frame |
|---|---|
| HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology | weeks 48, 96 and after 24 weeks of follow-up |
| Safety and tolerability: adverse events, laboratory parameters, vital signs | throughout 96 weeks of treatment |
Countries
Turkey (Türkiye)
Outcome results
None listed