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NCT01805882 · ClinicalTrials.gov registry record · Phase 2
Combination Therapy for Chronic Hepatitis C Infection
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 229
- Enrollment target
NCT01805882: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01805882 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 229 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805882, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 229 participants
- Enrollment target
Study Summary
Background: \- GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV) infection. GS-7977 may help treat the infection when used with other treatments like interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the body. Researchers want to see whether GS-7977 can be combined with any of the other three drugs to treat HCV infection. Some participants will take GS-7977 and GS-5885. Others will take GS-7977, GS-5885 and GS-9669 or GS-7977, GS-5885 and GS-9451. Objectives: \- To see whether GS-7977 with GS-5885 alone or in combination with either GS-9669 or 9451 can be used to treat HCV infection. Eligibility: Individuals at least 18 years of age who have chronic HCV infection and have never been treated for it. Individuals at least 18 years of age who have chronic HCV infection and have not responded to interferon therapy. Individuals at least 18 years of age who have chronic HCV infection with advanced liver disease and have never been treated for HCV Design: Participants will be screened with a physical exam and medical history. Blood samples will be collected. A liver biopsy may also be performed. Some participants will take the two study drugs and some will take three study drugs. Those who take GS-7977 and GS-5885 will have one daily tablet named fixed dose combination or FDC. Those who take GS-7977 and CS-9669 will have three daily tablets taken once daily. Those who take GS-7977 and GS-5885 and GS-9451 will take 2 pills once a day. GS-7977 and GS-5885 will be combined in one pill and GS-9451 will be in another pill. Treatment will be monitored with frequent blood tests. These tests will check liver function and the level of HCV infection. Participants may have other blood tests as needed for treatment. Participants will have 4, 6 or 12 weeks of treatment depending on which study drugs are scheduled to take. After they complete their schedule, they will stop treatment with the study dru
Primary Outcome
The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
Interventions
- DRUG Sofosbuvir
- DRUG GS-9451
- DRUG GS-9669
- DRUG Ledipasvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT01805882 record still lists
NCT01805882 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 4 interventions - of which Sofosbuvir is the first listed.
NCT01805882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01805882 about?
NCT01805882 is a clinical study titled "Combination Therapy for Chronic Hepatitis C Infection". Background: \- GS-7977, GS-5885, GS-9669, and GS-9451 are new drugs for treating hepatitis C virus (HCV) infection. GS-7977 may help treat the infection when used with other treatments like interferon therapy. GS-5885, and GS-9669, and GS-9451 also lower the amount of HCV in the body. Researchers w...
What is the current status of trial NCT01805882?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2013-01. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01805882?
The interventions under investigation include: Sofosbuvir (DRUG), GS-9451 (DRUG), GS-9669 (DRUG), Ledipasvir (DRUG).
Who is sponsoring clinical trial NCT01805882?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01805882's enrollment target sits among peer trials
229 264th of 2000 higher than 1,737 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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