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NCT02431312 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
A Phase 1 study, sponsored by Inovio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT02431312: Completed Phase 1 study, sponsored by Inovio Pharmaceuticals.
NCT02431312 is a Phase 1 study that has completed, run by Inovio Pharmaceuticals. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02431312, a Phase 1 study, has completed, sponsored by Inovio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen \[HBsAg\] and Hepatitis B core antigen \[HBcAg\]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.
Primary Outcome
Composite outcome measure consisting of multiple measures, including: 1. Local pain immediately after Study Treatment/EP and at select times using a visual analog scale (VAS) from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain" 2. Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP 3. Frequency and severity of laboratory abnormalities 4. Frequency and severity of all adverse events 5. Changes in vital signs
Interventions
- BIOLOGICAL INO-1800
- BIOLOGICAL INO-9112
- DRUG Nucleos(t)ide Analogue Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2015-01-12 |
| Est. Completion | 2018-05-22 |
| Phase | Phase 1 |
What the finished NCT02431312 record still lists
NCT02431312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 3 interventions - of which INO-1800 is the first listed.
NCT02431312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02431312 about?
NCT02431312 is a clinical study titled "Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects". This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen \[HBsAg\] and Hepatitis B core antigen \[HBcAg\]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electro...
What is the current status of trial NCT02431312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2015-01-12. Estimated completion is 2018-05-22.
What interventions are being tested in trial NCT02431312?
The interventions under investigation include: INO-1800 (BIOLOGICAL), INO-9112 (BIOLOGICAL), Nucleos(t)ide Analogue Treatment (DRUG).
Who is sponsoring clinical trial NCT02431312?
This trial is sponsored by Inovio Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02431312's enrollment target sits among peer trials
90 628th of 2000 higher than 1,352 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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