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NCT02339038 · ClinicalTrials.gov registry record · Phase 4
Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia
A Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 4
- Development phase
- 600
- Enrollment target
NCT02339038: Completed Phase 4 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT02339038 is a Phase 4 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 600 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02339038, a Phase 4 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 600 participants
- Enrollment target
Study Summary
Background: \- Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia. Objectives: \- To see if people can be treated for Hepatitis C safely and successfully in community-based health centers. Eligibility: \- Adults who need treatment for chronic Hepatitis C infection. Design: * Participants will be screened with blood tests. Their current medicines will be reviewed. * Participants will give researchers access to their medical records. Researchers will follow participants through these records. * Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits. * Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly. * Participants will have monthly follow-up visits for up to 3 months after they finish their medicine. * Participants will have yearly follow-up visits with their care provider for up to 10 years.
Primary Outcome
The primary outcome was the number 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 the limit of quantification (\<15IU/mL).
Interventions
- DRUG Ledipasvir 90 mg and Sofosbuvir 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2015-01-07 |
| Est. Completion | 2018-07-13 |
| Phase | Phase 4 |
What the finished NCT02339038 record still lists
NCT02339038 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 1 intervention - of which Ledipasvir 90 mg and Sofosbuvir 400 mg is the first listed.
NCT02339038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02339038 about?
NCT02339038 is a clinical study titled "Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia". Background: \- Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can...
What is the current status of trial NCT02339038?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 600 participants. The study started on 2015-01-07. Estimated completion is 2018-07-13.
What interventions are being tested in trial NCT02339038?
The interventions under investigation include: Ledipasvir 90 mg and Sofosbuvir 400 mg (DRUG).
Who is sponsoring clinical trial NCT02339038?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02339038's enrollment target sits among peer trials
600 137th of 2000 higher than 1,854 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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