Back to resultsA Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
Primary Purpose
Hepatitis D, Chronic
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
placebo
tenofovir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis D, Chronic
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
Sites / Locations
- Ankara University Medical Facility; Hepatology Department
- Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
- Dicle Uni Medical Faculty; Gastroenterology
- Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
- Ege Uni Medical Faculty Izmir; Gastroenterology
- Dokuz Eylul University Medical Faculty; Infection
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
proportion of patients becoming HDV-RNA negative
Secondary Outcome Measures
HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology
Safety and tolerability: adverse events, laboratory parameters, vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01088659
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2010 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
December 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis D, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180mcg sc weekly, 96 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
orally daily, 96 weeks
Intervention Type
Drug
Intervention Name(s)
tenofovir
Intervention Description
245mg po daily, 96 weeks
Primary Outcome Measure Information:
Title
proportion of patients becoming HDV-RNA negative
Time Frame
week 96
Secondary Outcome Measure Information:
Title
HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology
Time Frame
weeks 48, 96 and after 24 weeks of follow-up
Title
Safety and tolerability: adverse events, laboratory parameters, vital signs
Time Frame
throughout 96 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Ankara University Medical Facility; Hepatology Department
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Dicle Uni Medical Faculty; Gastroenterology
City
Diyarbakir
ZIP/Postal Code
10000
Country
Turkey
Facility Name
Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Ege Uni Medical Faculty Izmir; Gastroenterology
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty; Infection
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
30833068
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.
Results Reference
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A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
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