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COMPLETED Phase 1

A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment

NCT01185873 · View on ClinicalTrials.gov ↗

Study Summary

This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is 10 days.

Conditions Studied

Interventions

  • DRUG ritonavir
  • DRUG danoprevir

Study Locations (5)

Other

  • — Prague
  • — Prague
  • — Bratislava
  • — Bratislava

Kansas

  • — Lenexa

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2011-02
Est. Completion 2013-12
Phase Phase 1

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01185873

The ClinicalTrials.gov registry entry for NCT01185873 describes a study currently listed as completed. It is categorized as Phase 1, 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 81 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 Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions — of which ritonavir 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: NCT01185873 reports 5 study locations spanning 2 distinct geographic areas — top geographies include Other, Kansas. 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 NCT01185873 about?

NCT01185873 is a clinical study titled "A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment". This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses o...

What is the current status of trial NCT01185873?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2011-02. Estimated completion is 2013-12.

What conditions does trial NCT01185873 study?

This clinical trial studies the following conditions: Healthy Volunteer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01185873?

The interventions under investigation include: ritonavir (DRUG), danoprevir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01185873?

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 NCT01185873 being conducted?

This trial has 5 study locations across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial