A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
NCT ID: NCT02732639
Last Updated: 2016-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2005-10-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pegylated Interferon (PEG-IFN) alfa-2a
Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Pegylated Interferon (PEG-IFN) alfa-2a
Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
Interventions
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Pegylated Interferon (PEG-IFN) alfa-2a
Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive anti-delta for at least 3 months prior to screening
* Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
* A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
* Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug
Exclusion Criteria
* Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
* Evidence of decompensated liver disease
* Other medical condition associated with chronic liver disease
* Women with ongoing pregnancy or who are breast feeding
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Constanța, , Romania
Craiova, , Romania
Iași, , Romania
Timișoara, , Romania
Countries
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Other Identifiers
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ML18788
Identifier Type: -
Identifier Source: org_study_id
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