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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 206 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01022346
The ClinicalTrials.gov registry entry for NCT01022346 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01022346 reports 0 study locations.
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.
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