An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)

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: NCT01861444
Recruitment Status : Terminated (Terminated due to financial reasons.)
First Posted : May 23, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.

Condition or disease
Hepatitis D, Chronic

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg-interferon Alfa-2a Treatment in Patients With Chronic Hepatitis D (CHD)
Study Start Date : March 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection [ Time Frame: approximately 3.5 years ]
  2. Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment [ Time Frame: approximately 3.5 years ]

Secondary Outcome Measures :
  1. Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D [ Time Frame: approximately 3.5 years ]
  2. Proportion of chronic hepatitis D patients with liver cirrhosis [ Time Frame: approximately 3.5 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with chronic hepatitis B, and then those who are positive for anti-HDV Ab and treated with Pegasys

Inclusion Criteria:

For epidemiological part of the study:

  • Adult patients >/= 18 years of age
  • Positive HBsAg for at least 6 months

For the non-interventional section of the study

  • Adult patients, >/= 18 years of age
  • Positive HBsAg for at least 6 months
  • Positive anti-delta and positive HDV RNA by PCR
  • Elevated serum ALT >/= 2x ULN

Exclusion Criteria:

Patients with any of the following will not be eligible for treatment with Pegasys:

  • History of neurological disease
  • History of severe psychiatric disease
  • Decompensated diabetes
  • History of immunologically mediated disease
  • History of severe cardiac disease
  • History or other evidence of severe chronic pulmonary disease
  • Inadequate hematologic function

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): NCT01861444

Bucharest, Romania, 022328
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01861444     History of Changes
Other Study ID Numbers: ML25581
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis D
Hepatitis D, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents