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

August 9, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Missouri
      • Kansas City, Missouri, United States, 64128
      • St Louis, Missouri, United States, 63110
    • New York
      • New York, New York, United States, 10029
      • Syracuse, New York, United States, 13210
    • Ohio
      • Cleveland, Ohio, United States, 44106
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
    • Texas
      • Dallas, Texas, United States, 75203
      • Galveston, Texas, United States, 77555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
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
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
Percentage of participants with undetectable HCV RNA level
Time Frame: Week 12
Week 12
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
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
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
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
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
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
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
Percentage of participants with adverse events (AEs)
Time Frame: From Baseline to Week 12 (or up to Week 48 if treatment continued)
From Baseline to Week 12 (or up to Week 48 if treatment continued)
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)
From Baseline to Week 12 (or up to Week 48 if treatment continued)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2004

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2007

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP17355

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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