A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
NCT ID: NCT02864199
Last Updated: 2016-08-11
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
PHASE4
63 participants
INTERVENTIONAL
2004-02-29
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Moderate Renal Impairment
Participants with CrCl 30 to 50 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 micrograms (mcg) via subcutaneous (SC) injection once weekly, in combination with ribavirin, 600 milligrams (mg) orally (PO) daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.
Ribavirin
Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.
Group B: Severe Renal Impairment
Participants with CrCl \<30 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 mcg via SC injection once weekly, in combination with ribavirin, 400 mg PO daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.
Ribavirin
Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.
Group C: Hemodialysis/ESRD
Participants requiring hemodialysis will receive 12 weeks of peginterferon alfa-2a, 135 mcg via SC injection once weekly, in combination with ribavirin, 200 mg PO every morning. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.
Ribavirin
Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.
Group D: Normal Renal Function
Participants with CrCl \>80 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 mcg via SC injection once weekly, in combination with ribavirin, 800 to 1200 mg PO daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.
Ribavirin
Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.
Interventions
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Peginterferon alfa-2a
Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.
Ribavirin
Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CHC infection as shown on enzyme-linked immunosorbent assay (ELISA) and radioimmunoblot assay (RIBA) or quantifiable hepatitis C virus (HCV) ribonucleic acid (RNA) greater than (\>) 2000 copies per milliliter (copies/mL)
* Use of two forms of contraception during study and 6 months after the study in both men and women
* Normal renal function (creatinine clearance \[CrCl\] \>80 milliliters per minute \[mL/min\]), moderate renal impairment (CrCl 30 to 50 mL/min), severe renal impairment (CrCl less than \[\<\] 30 mL/min), or ESRD requiring hemodialysis
* Patients with ESRD must have been undergoing hemodialysis for at least 2 months
Exclusion Criteria
* Male partners of women who are pregnant
* Conditions associated with decompensated and/or chronic liver disease
* Human immunodeficiency virus (HIV) infection
* Interferon or ribavirin treatment within the previous 3 months
* Poor hematologic function, including unstable hemoglobin
* Significant comorbidity or severe illness which would make the participant unsuitable for the study
* Acute renal failure
18 Years
65 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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Birmingham, Alabama, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
New York, New York, United States
Syracuse, New York, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Galveston, Texas, United States
São Paulo, , Brazil
Marseille, , France
Christchurch, , New Zealand
Riccarton, Christchurch, , New Zealand
Huddinge, , Sweden
Countries
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Other Identifiers
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NP17355
Identifier Type: -
Identifier Source: org_study_id
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