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COMPLETED Phase 3

Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

NCT01625338 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Conditions Studied

Interventions

  • DRUG SOF
  • DRUG RBV
  • DRUG Peg-IFN

Study Locations (20)

California

  • Franco Felizarta, MD — Bakersfield
  • Arrowhead Regional Medical Center — Colton
  • Southern California Transplantation Institute, Research Foundation Liver Center — Coronado
  • eStudy Site — La Mesa
  • Kaiser Permanente — Los Angeles
  • Lightsource Medical/Peter J. Ruane MD, Inc. — Los Angeles
  • California Liver Institute — Los Angeles
  • Anthony Mills MD, Inc. — Los Angeles
  • eStudySite — Oceanside
  • University of California Davis Medical Center — Sacramento
  • University of California — San Diego
  • Resarch and Education, Inc. — San Diego
  • Medical Associates Research Group — San Diego
  • Kaiser Permanente — San Diego
  • Quest Clinical Research — San Francisco

Colorado

  • University of Colorado Hospital — Aurora
  • South Denver Gastroenterology, PC — Englewood

Alabama

  • University of Alabama at Birmingham — Birmingham

District of Columbia

  • Whitman-Walker Health — Washington D.C.

Florida

  • Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases — Bradenton

Trial Details

FieldValue
Enrollment Target 534 participants
Start Date 2012-06
Est. Completion 2014-12
Phase Phase 3

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01625338

The ClinicalTrials.gov registry entry for NCT01625338 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 534 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 3 interventions — of which SOF is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01625338 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01625338 about?

NCT01625338 is a clinical study titled "Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies". This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved ...

What is the current status of trial NCT01625338?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 534 participants. The study started on 2012-06. Estimated completion is 2014-12.

What conditions does trial NCT01625338 study?

This clinical trial studies the following conditions: Chronic Hepatitis C. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01625338?

The interventions under investigation include: SOF (DRUG), RBV (DRUG), Peg-IFN (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01625338?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01625338 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial