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NCT03312023 · ClinicalTrials.gov registry record · Phase 2
Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection
A Phase 2 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03312023: Completed Phase 2 study, sponsored by University of Maryland, Baltimore.
NCT03312023 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03312023, a Phase 2 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The goals of therapy against chronic hepatitis B are to decrease the morbidity and mortality related to chronic HBV infection. Currently available antiviral therapy can suppress viral replication but only a small proportion attain functional cure, which is defined as HBV surface antigen-to-antibody seroconversion. Hepatitis B surface antigen (HBsAg) is a marker of persistent hepatitis B infection. It has been observed that patients who had both hepatitis B and hepatitis C, and who were treated for their hepatitis C with 12 weeks of ledipasvir/sofosbuvir for had a decline in HBsAg levels. This study hypothesizes that a similar decrease would be seen in mono-infected hepatitis B subjects over the course of 12 weeks treatment with ledipasvir/sofosbuvir.
Primary Outcome
Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their HBsAg will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change (decline) in HBsAg from baseline to end of the 12 week treatment will be compared.
Interventions
- DRUG Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]
- DRUG Sofosbuvir 400 MG [Sovaldi]
- DRUG Ledipasvir 90 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 2 |
What the finished NCT03312023 record still lists
NCT03312023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni] is the first listed.
NCT03312023 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03312023 about?
NCT03312023 is a clinical study titled "Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection". The goals of therapy against chronic hepatitis B are to decrease the morbidity and mortality related to chronic HBV infection. Currently available antiviral therapy can suppress viral replication but only a small proportion attain functional cure, which is defined as HBV surface antigen-to-antibody ...
What is the current status of trial NCT03312023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-02-01. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03312023?
The interventions under investigation include: Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni] (DRUG), Sofosbuvir 400 MG [Sovaldi] (DRUG), Ledipasvir 90 MG (DRUG).
Who is sponsoring clinical trial NCT03312023?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03312023's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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