Study Stopped
Terminated due to financial reasons.
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)
1 other identifier
observational
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedNovember 2, 2016
November 1, 2016
4 years
May 2, 2013
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection
approximately 3.5 years
Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment
approximately 3.5 years
Secondary Outcomes (2)
Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D
approximately 3.5 years
Proportion of chronic hepatitis D patients with liver cirrhosis
approximately 3.5 years
Study Arms (1)
Cohort
Eligibility Criteria
Patients with chronic hepatitis B, and then those who are positive for anti-HDV Ab and treated with Pegasys
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Bucharest, 022328, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 23, 2013
Study Start
March 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11