Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01483742 · ClinicalTrials.gov registry record · Phase 2

A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

A Phase 2 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
43
Enrollment target
20
Study locations

NCT01483742 is a Phase 2 study of Hepatitis C, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 43 participants, below the 374-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 14 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01483742, a Phase 2 study of Hepatitis C, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
43 participants
Enrollment target
20
Study locations

Study Summary

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

Conditions Studied

Hepatitis C, Chronic

Interventions

  • DRUG ritonavir
  • DRUG ribavirin
  • DRUG danoprevir
  • DRUG RO5024048
  • DRUG peginterferon alfa-2a [Pegasys]

Study Locations (20)

California

  • - Anaheim
  • - Coronado
  • - La Jolla
  • - Long Beach

Florida

  • - DeLand
  • - Miami
  • - Orlando

Georgia

  • - Atlanta
  • - Atlanta

Alabama

  • - Birmingham

Louisiana

  • - New Orleans

Michigan

  • - Detroit

New Jersey

  • - Hillsborough

New York

  • - New York

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2012-04
Est. Completion 2013-09
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01483742

The ClinicalTrials.gov registry entry for NCT01483742 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (89% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 5 interventions - of which ritonavir is the first listed.

NCT01483742 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01483742 about?

NCT01483742 is a clinical study titled "A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis". This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null ...

What is the current status of trial NCT01483742?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2012-04. Estimated completion is 2013-09.

What conditions does trial NCT01483742 study?

This clinical trial studies the following conditions: Hepatitis C, Chronic.

What interventions are being tested in trial NCT01483742?

The interventions under investigation include: ritonavir (DRUG), ribavirin (DRUG), danoprevir (DRUG), RO5024048 (DRUG), peginterferon alfa-2a [Pegasys] (DRUG).

Who is sponsoring clinical trial NCT01483742?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01483742 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Hepatitis C, Chronic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Hepatitis C, Chronic

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.