NCT02864199

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_4

Geographic Reach
5 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

3.6 years

First QC Date

August 9, 2016

Last Update Submit

August 9, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (7)

  • Cmax of peginterferon alfa-2a

    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

    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

    Week 12

  • Cmax of ribavirin

    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

    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

    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

    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 Outcomes (5)

  • Time of maximum concentration (Tmax) of peginterferon alfa-2a

    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

    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

    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)

    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

    From Baseline to Week 12 (or up to Week 48 if treatment continued)

Study Arms (4)

Group A: Moderate Renal Impairment

EXPERIMENTAL

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-2aDrug: Ribavirin

Group B: Severe Renal Impairment

EXPERIMENTAL

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-2aDrug: Ribavirin

Group C: Hemodialysis/ESRD

EXPERIMENTAL

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-2aDrug: Ribavirin

Group D: Normal Renal Function

EXPERIMENTAL

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-2aDrug: Ribavirin

Interventions

Peginterferon alfa-2aDRUG

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.

Also known as: Pegasys
Group A: Moderate Renal ImpairmentGroup B: Severe Renal ImpairmentGroup C: Hemodialysis/ESRDGroup D: Normal Renal Function
RibavirinDRUG

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.

Also known as: Copegus
Group A: Moderate Renal ImpairmentGroup B: Severe Renal ImpairmentGroup C: Hemodialysis/ESRDGroup D: Normal Renal Function

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

New Orleans, Louisiana, 70112, United States

Location

Unknown Facility

Kansas City, Missouri, 64128, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

Syracuse, New York, 13210, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Dallas, Texas, 75203, United States

Location

Unknown Facility

Galveston, Texas, 77555, United States

Location

Unknown Facility

São Paulo, 04038-002, Brazil

Location

Unknown Facility

Marseille, 13285, France

Location

Unknown Facility

Christchurch, 8011, New Zealand

Location

Unknown Facility

Riccarton, Christchurch, 8011, New Zealand

Location

Unknown Facility

Huddinge, 14186, Sweden

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 11, 2016

Study Start

February 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

NZ(2)US(12)FR(1)SE(1)BR(1)