Clinical trial NCT01088659: A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis D, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: proportion of patients becoming HDV-RNA negative
timeFrame: week 96
Secondary outcomes:
measure: HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology
timeFrame: weeks 48, 96 and after 24 weeks of follow-up
measure: Safety and tolerability: adverse events, laboratory parameters, vital signs
timeFrame: throughout 96 weeks of treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical Facility; Hepatology Department
city: Bursa
country: Turkey
facility: Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
city: Diyarbakir
country: Turkey
facility: Dicle Uni Medical Faculty; Gastroenterology
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty Izmir; Gastroenterology
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty; Infection
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7.