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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: Completed Phase 1 study of Hepatitis C, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.
Conditions Studied
Interventions
- DRUG RBV
- DRUG GS7977
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01441180 record still lists
NCT01441180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01441180's enrollment target sits among peer trials
60 68th of 106 higher than 38 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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