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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01088659
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : January 14, 2019
Information provided by (Responsible Party):
Hoffmann-La Roche

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

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Study Type : Interventional  (Clinical Trial)
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 : February 16, 2010
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : December 29, 2017

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

Primary Outcome Measures :
  1. proportion of patients becoming HDV-RNA negative [ Time Frame: week 96 ]

Secondary Outcome Measures :
  1. HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology [ Time Frame: weeks 48, 96 and after 24 weeks of follow-up ]
  2. Safety and tolerability: adverse events, laboratory parameters, vital signs [ Time Frame: throughout 96 weeks of treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01088659

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Ankara University Medical Facility; Hepatology Department
Ankara, Turkey, 06620
Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
Bursa, Turkey, 16059
Dicle Uni Medical Faculty; Gastroenterology
Diyarbakir, Turkey, 10000
Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
Istanbul, Turkey, 34390
Ege Uni Medical Faculty Izmir; Gastroenterology
Izmir, Turkey, 35100
Dokuz Eylul University Medical Faculty; Infection
Izmir, Turkey, 35340
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT01088659    
Other Study ID Numbers: ML22364
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis D
Hepatitis D, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents