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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01861444
First received: May 2, 2013
Last updated: August 4, 2014
Last verified: August 2014

May 2, 2013
August 4, 2014
March 2011
October 2014   (final data collection date for primary outcome measure)
  • Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01861444 on ClinicalTrials.gov Archive Site
  • Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Proportion of chronic hepatitis D patients with liver cirrhosis [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
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An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)
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)

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with chronic hepatitis B, and then those who are positive for anti-HDV Ab and treated with Pegasys

Hepatitis D, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT01861444
ML25581
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP