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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Hoffmann-La Roche

909 total trials

What the finished NCT01483742 record still lists

NCT01483742 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 374-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (89% lower).

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 names 20 study sites across 14 states, led by 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.

Where NCT01483742's enrollment target sits among peer trials

43 26th of 26 higher than 1 of 26 other Hepatitis C, Chronic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01483742, the US trial registry maintained by the National Library of Medicine. NCT01483742 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.