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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

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ClinicalTrials.gov Identifier: NCT02864199
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Peginterferon alfa-2a Drug: Ribavirin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairment, or End-Stage Renal Disease Undergoing Hemodialysis
Study Start Date : February 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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.
Other Name: Pegasys

Drug: 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 Name: Copegus
Experimental: 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.
 Drug: 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.
Other Name: Pegasys

Drug: 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 Name: Copegus
Experimental: 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.
 Drug: 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.
Other Name: Pegasys

Drug: 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 Name: Copegus
Experimental: 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.
 Drug: 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.
Other Name: Pegasys

Drug: 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 Name: Copegus


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of peginterferon alfa-2a [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]
  2. CL/F of ribavirin [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]
  3. Percentage of participants with undetectable HCV RNA level [ Time Frame: Week 12 ]
  4. Cmax of ribavirin [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]
  5. AUC of ribavirin [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]
  6. AUC of peginterferon alfa-2a [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]
  7. Clearance (CL/F) of peginterferon alfa-2a [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]

Secondary Outcome Measures :
  1. Time of maximum concentration (Tmax) of peginterferon alfa-2a [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]
  2. Tmax of ribavirin [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]
  3. Plasma concentration of ribavirin [ Time Frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 ]
  4. Percentage of participants with adverse events (AEs) [ Time Frame: From Baseline to Week 12 (or up to Week 48 if treatment continued) ]
  5. Percentage of participants with a dose modification or premature withdrawal for safety reasons [ Time Frame: From Baseline to Week 12 (or up to Week 48 if treatment continued) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 to 65 years of age
  • 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:

  • Women who are pregnant or breastfeeding
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864199


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Missouri
Kansas City, Missouri, United States, 64128
St Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10029
Syracuse, New York, United States, 13210
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Dallas, Texas, United States, 75203
Galveston, Texas, United States, 77555
Brazil
Sao Paulo, Brazil, 04038-002
France
Marseille, France, 13285
New Zealand
Christchurch, New Zealand, 8011
Riccarton, Christchurch, New Zealand, 8011
Sweden
Huddinge, Sweden, 14186
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02864199    
Other Study ID Numbers: NP17355
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Renal Insufficiency
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Kidney Diseases
Urologic Diseases
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents