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NCT01851330 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)

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

Completed
Registry status
Phase 3
Development phase
647
Enrollment target
20
Study locations

NCT01851330: Completed Phase 3 study of Chronic Hepatitis C Virus, sponsored by Gilead Sciences.

NCT01851330 is a Phase 3 study of Chronic Hepatitis C Virus that has completed, run by Gilead Sciences. The registered enrollment target is 647 participants, above the 147-participant average among 3 other Chronic Hepatitis C Virus trials with a reported enrollment target (340% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01851330, a Phase 3 study of Chronic Hepatitis C Virus, has completed, sponsored by Gilead Sciences.

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

Study Summary

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.

Primary Outcome

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.

Conditions Studied

Chronic Hepatitis C Virus

Interventions

  • DRUG RBV
  • DRUG LDV/SOF

Study Locations (20)

California

  • - La Jolla
  • - Los Angeles
  • - Palo Alto
  • - Sacramento
  • - San Diego
  • - San Francisco

Florida

  • - Gainesville
  • - Jacksonville
  • - Miami
  • - Orlando
  • - Wellington

Georgia

  • - Atlanta
  • - Decatur
  • - Marietta

Colorado

  • - Aurora
  • - Englewood

Alabama

  • - Birmingham

District of Columbia

  • - Washington D.C.

Illinois

  • - Chicago

Indiana

  • - Indianapolis

Trial Details

FieldValue
Enrollment Target 647 participants
Start Date 2013-05
Est. Completion 2014-03
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT01851330 record still lists

NCT01851330 is an interventional study that assigns participants to a tested intervention. The registered 647 participants enrollment target is mid-sized for trials with a published cap, above the 147-participant average among 3 other Chronic Hepatitis C Virus trials with a reported enrollment target (340% higher).

The record links to 1 condition, with Chronic Hepatitis C Virus appearing as the primary indexed condition, and to 2 interventions - of which RBV is the first listed.

NCT01851330 names 20 study sites across 8 states, led by California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01851330 about?

NCT01851330 is a clinical study titled "Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)". This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive participants with chronic genotype 1 HCV infection.

What is the current status of trial NCT01851330?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 647 participants. The study started on 2013-05. Estimated completion is 2014-03.

What conditions does trial NCT01851330 study?

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

What interventions are being tested in trial NCT01851330?

The interventions under investigation include: RBV (DRUG), LDV/SOF (DRUG).

Who is sponsoring clinical trial NCT01851330?

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

Where is trial NCT01851330 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01851330, the US trial registry maintained by the National Library of Medicine. NCT01851330 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.