A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
NCT ID: NCT02731131
Last Updated: 2016-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2004-09-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Monotherapy with Peginterferon alfa-2a
Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
Group B: Combination with Peginterferon alfa-2a + Ribavirin
Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
Ribavirin
Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
Interventions
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Peginterferon alfa-2a
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
Ribavirin
Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive anti-delta for the prior 3 months
* Positive HDV RNA at Screening
* Elevated ALT (1 to 10 times upper limit of normal) prior to first dose
* Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)
* Negative pregnancy and adequate contraceptive use
Exclusion Criteria
* Positive for hepatitis A or C, or human immunodeficiency virus (HIV)
* Increased risk of metabolic liver disease
* Decompensated liver disease
* Elevated bilirubin
* Poor hematologic or renal function
* Drug/alcohol abuse within 1 year prior to study
* History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease
* Organ transplantation with existing functional graft
* Retinopathy or other ophthalmologic complication of diabetes or hypertension
* Inclusion in another investigational trial within previous 12 weeks
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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Cagliari, , Italy
Countries
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Other Identifiers
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ML18149
Identifier Type: -
Identifier Source: org_study_id
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