A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
Status and phase
Completed
Phase 3
Conditions
Hepatitis D, Chronic
Treatments
Drug: tenofovir
Drug: placebo
Drug: peginterferon alfa-2a [Pegasys]
Details and patient eligibility
About
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.
Enrollment
50 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
50 participants in 2 patient groups
1
Experimental group
Treatment:
Drug: placebo
Drug: peginterferon alfa-2a [Pegasys]
2
Experimental group
Treatment:
Drug: tenofovir
Drug: peginterferon alfa-2a [Pegasys]
Trial contacts and locations
6
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Data sourced from clinicaltrials.gov
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