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NCT01022346 · ClinicalTrials.gov registry record · Phase 2
A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
NCT01022346: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01022346 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 206 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01022346, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.
Interventions
- DRUG Placebo
- DRUG RO5217790
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01022346 record still lists
NCT01022346 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01022346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01022346 about?
NCT01022346 is a clinical study titled "A Study of RO5217790 in Participants With High Grade Cervical Intraepithelial Neoplasia (CIN) Associated With High Risk Human Papillomavirus (HR-HPV) Infection". This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either pla...
What is the current status of trial NCT01022346?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2009-08. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01022346?
The interventions under investigation include: Placebo (DRUG), RO5217790 (DRUG).
Who is sponsoring clinical trial NCT01022346?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01022346's enrollment target sits among peer trials
206 298th of 2000 higher than 1,703 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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