Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01259726 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 173
- Enrollment target
NCT01259726: Completed Phase 2 study, sponsored by Shire.
NCT01259726 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 173 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01259726, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 173 participants
- Enrollment target
Study Summary
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.
Primary Outcome
An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment per
Interventions
- OTHER Placebo
- BIOLOGICAL VP20621
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2011-06-27 |
| Est. Completion | 2013-06-11 |
| Phase | Phase 2 |
What the finished NCT01259726 record still lists
NCT01259726 is an interventional study that assigns participants to a tested intervention. The registered 173 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 (30% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01259726 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01259726 about?
NCT01259726 is a clinical study titled "Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection". The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy o...
What is the current status of trial NCT01259726?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 173 participants. The study started on 2011-06-27. Estimated completion is 2013-06-11.
What interventions are being tested in trial NCT01259726?
The interventions under investigation include: Placebo (OTHER), VP20621 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01259726?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01259726's enrollment target sits among peer trials
173 397th of 2000 higher than 1,604 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05568719 · 173 participants · Phase 3
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
- NCT07070115 · 173 participants · NA
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
- NCT07150832 · 173 participants · NA
Efficacy of the I-CARE Digital Health Intervention
- NCT01000259 · 174 participants
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI