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NCT01962441 · ClinicalTrials.gov registry record · Phase 3

SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

A Phase 3 study of Hepatitis C, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
601
Enrollment target
20
Study locations

NCT01962441: Completed Phase 3 study of Hepatitis C, sponsored by Gilead Sciences.

NCT01962441 is a Phase 3 study of Hepatitis C that has completed, run by Gilead Sciences. The registered enrollment target is 601 participants, below the 1,884-participant average among 106 other Hepatitis C trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01962441, a Phase 3 study of Hepatitis C, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
601 participants
Enrollment target
20
Study locations

Study Summary

This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.

Primary Outcome

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Conditions Studied

Hepatitis C

Interventions

  • DRUG SOF
  • DRUG RBV
  • DRUG Peg-IFN

Study Locations (20)

California

  • - Riverside
  • - San Diego
  • - San Francisco

Tennessee

  • - Germantown
  • - Nashville
  • - Nashville

Colorado

  • - Aurora
  • - Englewood

Florida

  • - Miami
  • - Wellington

New Jersey

  • - Hillsborough
  • - Newark

New York

  • - Binghamton
  • - New York

Georgia

  • - Marietta

Louisiana

  • - New Orleans

Trial Details

FieldValue
Enrollment Target 601 participants
Start Date 2013-09-24
Est. Completion 2016-07-07
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT01962441 record still lists

NCT01962441 is an interventional study that assigns participants to a tested intervention. The registered 601 participants enrollment target is mid-sized for trials with a published cap, below the 1,884-participant average among 106 other Hepatitis C trials with a reported enrollment target (68% lower).

The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which SOF is the first listed.

NCT01962441 names 20 study sites across 12 states, led by California, Tennessee, Colorado.

Frequently Asked Questions

What is clinical trial NCT01962441 about?

NCT01962441 is a clinical study titled "SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection". This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and ...

What is the current status of trial NCT01962441?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2013-09-24. Estimated completion is 2016-07-07.

What conditions does trial NCT01962441 study?

This clinical trial studies the following conditions: Hepatitis C.

What interventions are being tested in trial NCT01962441?

The interventions under investigation include: SOF (DRUG), RBV (DRUG), Peg-IFN (DRUG).

Who is sponsoring clinical trial NCT01962441?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01962441 being conducted?

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

Learn More About Clinical Trials

Similar trials for Hepatitis C

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 NCT01962441's enrollment target sits among peer trials

601 16th of 106 higher than 91 of 106 other Hepatitis C trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C 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 NCT01962441, the US trial registry maintained by the National Library of Medicine. NCT01962441 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.