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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
NCT02864199 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG Peginterferon alfa-2a
Study Locations (17)
Other
- — São Paulo
- — Marseille
- — Christchurch
- — Riccarton, Christchurch
- — Huddinge
Missouri
- — Kansas City
- — St Louis
New York
- — New York
- — Syracuse
Texas
- — Dallas
- — Galveston
Alabama
- — Birmingham
Kansas
- — Kansas City
Louisiana
- — New Orleans
Ohio
- — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2004-02 |
| Est. Completion | 2007-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02864199
The ClinicalTrials.gov registry entry for NCT02864199 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 2 interventions — of which Ribavirin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02864199 reports 17 study locations spanning 10 distinct geographic areas — top geographies include Other, Missouri, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02864199 about?
NCT02864199 is a clinical study titled "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". 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...
What is the current status of trial NCT02864199?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2004-02. Estimated completion is 2007-09.
What conditions does trial NCT02864199 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02864199?
The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02864199?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02864199 being conducted?
This trial has 17 study locations across Alabama, Kansas, Louisiana, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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