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NCT01441180 · ClinicalTrials.gov registry record · Phase 1

GS-7977 With Ribavirin for Hepatitis C (SPARE)

A Phase 1 study of Hepatitis C, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT01441180 is a Phase 1 study of Hepatitis C that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01441180, a Phase 1 study of Hepatitis C, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

Background: \- GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by blocking the hepatitis C virus from dividing in the body. This medication has been used along with other medications commonly used to treat hepatitis C, such as interferon and ribavirin. When used with interferon and ribavirin, GS-7977 seems to be very effective in eliminating the hepatitis C virus from the body. However, interferon can have serious side effects, so researchers want to see if GS-7977 can work by itself or with only ribavirin. Objectives: \- To test the safety and effectiveness of GS-7977 alone or given with ribavirin for hepatitis C infection. Eligibility: \- Individuals at least 18 years of age who have hepatitis C with liver disease, and have never received drugs for it. Design: * This study will require multiple clinic visits over 18 months. A liver biopsy will be required before the start of the study if participants have not had one within the past 3 years. * Participants will be screened with a medical history and physical exam. * Participants will have either GS-7977 alone or GS-7977 with ribavirin. GS-7977 is taken by mouth once a day. Ribavirin is taken by mouth in the morning and evening. * Participants will have study visits on Days 1, 3, 5, 7, 10, and 14. These visits will involve regular blood tests and symptom monitoring. * After the second week, participants will have study visits during Weeks 3, 4, 6, 8, 12, 16, and 20. Blood and urine tests will be given to study virus levels in the body, and symptoms will be discussed. * Participants will stop receiving the study drugs at Week 24. * Followup clinic visits with blood tests will take place in Weeks 28, 36, 48, 52, 60, and 72. Another liver biopsy will be performed at 48 weeks. * Some participants may also be part of a smaller study. This study involves frequent blood draws to study drug and virus levels in the blood. The study will require a 36-hour hospital inpatient visit

Conditions Studied

Hepatitis C

Interventions

  • DRUG RBV
  • DRUG GS7977

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-09
Est. Completion 2014-07
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT01441180

The ClinicalTrials.gov registry entry for NCT01441180 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (97% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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

NCT01441180 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01441180 about?

NCT01441180 is a clinical study titled "GS-7977 With Ribavirin for Hepatitis C (SPARE)". Background: \- GS-7977 is a new drug that is being developed to treat hepatitis C infection. It works by blocking the hepatitis C virus from dividing in the body. This medication has been used along with other medications commonly used to treat hepatitis C, such as interferon and ribavirin. When us...

What is the current status of trial NCT01441180?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-09. Estimated completion is 2014-07.

What conditions does trial NCT01441180 study?

This clinical trial studies the following conditions: Hepatitis C.

What interventions are being tested in trial NCT01441180?

The interventions under investigation include: RBV (DRUG), GS7977 (DRUG).

Who is sponsoring clinical trial NCT01441180?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01441180 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.