NCT01088659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

7.9 years

First QC Date

March 16, 2010

Last Update Submit

January 11, 2019

Conditions

Hepatitis D, Chronic

Outcome Measures

Primary Outcomes (1)

  • proportion of patients becoming HDV-RNA negative

    week 96

Secondary Outcomes (2)

  • HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology

    weeks 48, 96 and after 24 weeks of follow-up

  • Safety and tolerability: adverse events, laboratory parameters, vital signs

    throughout 96 weeks of treatment

Study Arms (2)

1

EXPERIMENTAL
Drug: peginterferon alfa-2a [Pegasys]Drug: placebo

2

EXPERIMENTAL
Drug: peginterferon alfa-2a [Pegasys]Drug: tenofovir

Interventions

peginterferon alfa-2a [Pegasys]DRUG

180mcg sc weekly, 96 weeks

12
placeboDRUG

orally daily, 96 weeks

1
tenofovirDRUG

245mg po daily, 96 weeks

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ankara University Medical Facility; Hepatology Department

Ankara, 06620, Turkey (Türkiye)

Location

Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali

Bursa, 16059, Turkey (Türkiye)

Location

Dicle Uni Medical Faculty; Gastroenterology

Diyarbakır, 10000, Turkey (Türkiye)

Location

Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy

Istanbul, 34390, Turkey (Türkiye)

Location

Ege Uni Medical Faculty Izmir; Gastroenterology

Izmir, 35100, Turkey (Türkiye)

Location

Dokuz Eylul University Medical Faculty; Infection

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 30833068DERIVED

MeSH Terms

Conditions

Hepatitis D, Chronic

Interventions

peginterferon alfa-2aTenofovir

Condition Hierarchy (Ancestors)

Hepatitis DHepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

February 16, 2010

Primary Completion

December 29, 2017

Study Completion

December 29, 2017

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

TU(6)