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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis D, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Bucharest, , Romania

Site Status

Countries

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Romania

Other Identifiers

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ML25581

Identifier Type: -

Identifier Source: org_study_id