A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01088659

Collaborator

(none)

Enrollment

Locations

Arms

94.4

Actual Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis D, Chronic	Drug: peginterferon alfa-2a [Pegasys] Drug: placebo Drug: tenofovir	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 16, 2010

Actual Primary Completion Date :

Dec 29, 2017

Actual Study Completion Date :

Dec 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: peginterferon alfa-2a [Pegasys] 180mcg sc weekly, 96 weeks Drug: placebo orally daily, 96 weeks
Experimental: 2	Drug: peginterferon alfa-2a [Pegasys] 180mcg sc weekly, 96 weeks Drug: tenofovir 245mg po daily, 96 weeks

Arm

Intervention/Treatment

Experimental: 1

Drug: peginterferon alfa-2a [Pegasys]

180mcg sc weekly, 96 weeks

Drug: placebo

orally daily, 96 weeks

Experimental: 2

Drug: peginterferon alfa-2a [Pegasys]

180mcg sc weekly, 96 weeks

Drug: tenofovir

245mg po daily, 96 weeks

Outcome Measures

Primary Outcome Measures

proportion of patients becoming HDV-RNA negative [week 96]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ankara University Medical Facility; Hepatology Department	Ankara	Turkey	06620
2	Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali	Bursa	Turkey	16059
3	Dicle Uni Medical Faculty; Gastroenterology	Diyarbakir	Turkey	10000
4	Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy	Istanbul	Turkey	34390
5	Ege Uni Medical Faculty Izmir; Gastroenterology	Izmir	Turkey	35100
6	Dokuz Eylul University Medical Faculty; Infection	Izmir	Turkey	35340