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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: March 16, 2010
Last updated: May 4, 2016
Last verified: May 2016
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 Intervention Phase
Hepatitis D, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: placebo
Drug: tenofovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • proportion of patients becoming HDV-RNA negative [ Time Frame: week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology [ Time Frame: weeks 48, 96 and after 24 weeks of follow-up ] [ Designated as safety issue: No ]
  • Safety and tolerability: adverse events, laboratory parameters, vital signs [ Time Frame: throughout 96 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01088659

Ankara, Turkey, 06620
Bursa, Turkey, 16059
Diyarbakir, Turkey, 10000
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
Izmir, Turkey, 35340
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01088659     History of Changes
Other Study ID Numbers: ML22364 
Study First Received: March 16, 2010
Last Updated: May 4, 2016
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Hepatitis D
Hepatitis D, Chronic
Hepatitis A
Digestive System Diseases
Enterovirus Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on May 24, 2016