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

Hepatitis D, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088659
• Other study ID #: ML22364
• Status: Completed
• Phase: Phase 3
• Start date: February 16, 2010
• Est. completion date: December 29, 2017

Study information

• Verified date: January 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis D, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
180mcg sc weekly, 96 weeks
• placebo
orally daily, 96 weeks
• tenofovir
245mg po daily, 96 weeks

Locations

Country	Name	City	State
Turkey	Ankara University Medical Facility; Hepatology Department	Ankara
Turkey	Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali	Bursa
Turkey	Dicle Uni Medical Faculty; Gastroenterology	Diyarbakir
Turkey	Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy	Istanbul
Turkey	Dokuz Eylul University Medical Faculty; Infection	Izmir
Turkey	Ege Uni Medical Faculty Izmir; Gastroenterology	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients becoming HDV-RNA negative		week 96
Secondary	HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology		weeks 48, 96 and after 24 weeks of follow-up
Secondary	Safety and tolerability: adverse events, laboratory parameters, vital signs		throughout 96 weeks of treatment