A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy
NCT ID: NCT01337375
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2011-03-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A/B
peginterferon alfa 2a [Pegasys]
sc weekly
peginterferon alfa-2a [Pegasys]
iv weekly
C/D
peginterferon alfa-2a [Pegasys]
sc twice weekly
peginterferon alfa-2a [Pegasys]
iv twice weekly
Interventions
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peginterferon alfa 2a [Pegasys]
sc weekly
peginterferon alfa-2a [Pegasys]
iv weekly
peginterferon alfa-2a [Pegasys]
sc twice weekly
peginterferon alfa-2a [Pegasys]
iv twice weekly
Eligibility Criteria
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Inclusion Criteria
* Hepatitis C, genotype 1
* Non-responder to previous anti-HCV therapy with peginterferon alfa and ribavirin
* Compensated liver disease (Child-Pugh class A) for \>/= 24 months before baseline
* Positive for anti-HCV for \> 6 months, with detectable serum HCV-RNA
Exclusion Criteria
* HCV infection other than genotype 1
* Positive for Hepatitis A, Hepatitis B or HIV infection at screening
* Chronic Hepatitis of other than HCV origin
* Decompensated liver disease (Child-Pugh class B or C)
* Therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study
* Clinically relevant retina disorder
* Pregnant or lactating women and male partners of pregnant women
18 Years
70 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_DIRECTOR
Hoffmann-La Roche
Locations
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Berlin, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Hanover, , Germany
Leipzig, , Germany
Countries
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Other Identifiers
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ML22936
Identifier Type: -
Identifier Source: org_study_id