A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
This trial is active, not recruiting.
|Condition||hepatitis d, chronic|
|Treatments||peginterferon alfa-2a [pegasys], placebo, tenofovir|
|Start date||February 2010|
|End date||December 2017|
|Trial size||50 participants|
|Trial identifier||NCT01088659, ML22364|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Ankara, Turkey 06620||not available||no longer recruiting|
|Bursa, Turkey 16059||not available||no longer recruiting|
|Diyarbakir, Turkey 10000||not available||no longer recruiting|
|Istanbul, Turkey 34390||not available||no longer recruiting|
|Izmir, Turkey 35100||not available||no longer recruiting|
|Izmir, Turkey 35340||not available||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
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
Male or female participants at least 18 years old.
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
|Official title||A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis|
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