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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2014 by Hoffmann-La Roche.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 2, 2013
Last updated: October 20, 2014
Last verified: October 2014
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.

Hepatitis D, Chronic

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: March 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01861444

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01861444     History of Changes
Other Study ID Numbers: ML25581 
Study First Received: May 2, 2013
Last Updated: October 20, 2014
Health Authority: Romania: National Medicines Agency

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 processed this record on October 21, 2016