Overview

This trial is active, not recruiting.

Condition hepatitis d, chronic
Treatments peginterferon alfa-2a [pegasys], placebo, tenofovir
Phase phase 3
Sponsor Hoffmann-La Roche
Start date February 2010
End date December 2017
Trial size 50 participants
Trial identifier NCT01088659, ML22364

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
peginterferon alfa-2a [pegasys]
180mcg sc weekly, 96 weeks
placebo
orally daily, 96 weeks
(Experimental)
peginterferon alfa-2a [pegasys]
180mcg sc weekly, 96 weeks
tenofovir
245mg po daily, 96 weeks

Primary Outcomes

Measure
proportion of patients becoming HDV-RNA negative
time frame: week 96

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.