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NCT03073967 · ClinicalTrials.gov registry record · Phase 3
Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects
A Phase 3 study, sponsored by AiCuris Anti-infective Cures.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
NCT03073967: Completed Phase 3 study, sponsored by AiCuris Anti-infective Cures.
NCT03073967 is a Phase 3 study that has completed, run by AiCuris Anti-infective Cures. The registered enrollment target is 158 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03073967, a Phase 3 study, has completed, sponsored by AiCuris Anti-infective Cures.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
Study Summary
Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).
Primary Outcome
Number of subjects cured (all lesions healed as assessed by the Investigator) during the treatment period of up to 28 days relative to the total number of subjects treated with trial medication in the respective treatment group.
Interventions
- DRUG Pritelivir
- DRUG Investigator's choice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2025-11-11 |
| Phase | Phase 3 |
What the finished NCT03073967 record still lists
NCT03073967 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Pritelivir is the first listed.
NCT03073967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03073967 about?
NCT03073967 is a clinical study titled "Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects". Randomized, open-label, multi-center, comparative trial to assess the efficacy and safety in immunocompromised subjects with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidl...
What is the current status of trial NCT03073967?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2017-05-08. Estimated completion is 2025-11-11.
What interventions are being tested in trial NCT03073967?
The interventions under investigation include: Pritelivir (DRUG), Investigator's choice (DRUG).
Who is sponsoring clinical trial NCT03073967?
This trial is sponsored by AiCuris Anti-infective Cures, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03073967's enrollment target sits among peer trials
158 1502nd of 2000 higher than 496 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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