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NCT01687257 · ClinicalTrials.gov registry record · Phase 2

Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation

A Phase 2 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT01687257 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 50 participants.

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The verdict

NCT01687257, a Phase 2 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.

Interventions

  • DRUG SOF
  • DRUG RBV

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2012-07
Est. Completion 2015-10
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT01687257

The ClinicalTrials.gov registry entry for NCT01687257 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which SOF is the first listed.

NCT01687257 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01687257 about?

NCT01687257 is a clinical study titled "Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation". This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks o...

What is the current status of trial NCT01687257?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-07. Estimated completion is 2015-10.

What interventions are being tested in trial NCT01687257?

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

Who is sponsoring clinical trial NCT01687257?

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

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.