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NCT02201953 · ClinicalTrials.gov registry record · Phase 3

Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection

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

Completed
Registry status
Phase 3
Development phase
558
Enrollment target
20
Study locations

NCT02201953: Completed Phase 3 study of Hepatitis C Virus Infection, sponsored by Gilead Sciences.

NCT02201953 is a Phase 3 study of Hepatitis C Virus Infection that has completed, run by Gilead Sciences. The registered enrollment target is 558 participants, above the 91-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (513% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02201953, a Phase 3 study of Hepatitis C Virus Infection, has completed, sponsored by Gilead Sciences.

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

Study Summary

The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (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 Virus Infection

Interventions

  • DRUG SOF
  • DRUG RBV
  • DRUG SOF/VEL

Study Locations (20)

Florida

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

California

  • - Los Angeles
  • - Los Angeles
  • - Sacramento
  • - San Diego

New York

  • - New York
  • - The Bronx

Colorado

  • - Aurora

Georgia

  • - Marietta

Illinois

  • - Chicago

Indiana

  • - Indianapolis

Maryland

  • - Lutherville

Trial Details

FieldValue
Enrollment Target 558 participants
Start Date 2014-07
Est. Completion 2015-12
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT02201953 record still lists

NCT02201953 is an interventional study that assigns participants to a tested intervention. The registered 558 participants enrollment target is mid-sized for trials with a published cap, above the 91-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (513% higher).

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

NCT02201953 names 20 study sites across 12 states, led by Florida, California, New York.

Frequently Asked Questions

What is clinical trial NCT02201953 about?

NCT02201953 is a clinical study titled "Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection". The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in particip...

What is the current status of trial NCT02201953?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2014-07. Estimated completion is 2015-12.

What conditions does trial NCT02201953 study?

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

What interventions are being tested in trial NCT02201953?

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

Who is sponsoring clinical trial NCT02201953?

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

Where is trial NCT02201953 being conducted?

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

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Related registry views

Source: ClinicalTrials.gov NCT02201953, the US trial registry maintained by the National Library of Medicine. NCT02201953 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.