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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 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03312023
The ClinicalTrials.gov registry entry for NCT03312023 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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