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Terminated due to financial reasons.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
For epidemiological part of the study:
For the non-interventional section of the study
Exclusion Criteria:
Patients with any of the following will not be eligible for treatment with Pegasys:
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Patients with chronic hepatitis B, and then those who are positive for anti-HDV Ab and treated with Pegasys
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucharest | 022328 | Romania |
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| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| D012327 |
| RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |