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NCT01233960 · ClinicalTrials.gov registry record · Phase 3

Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

A Phase 3 study, sponsored by Mesoblast.

Completed
Registry status
Phase 3
Development phase
73
Enrollment target

NCT01233960: Completed Phase 3 study, sponsored by Mesoblast.

NCT01233960 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 73 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01233960, a Phase 3 study, has completed, sponsored by Mesoblast.

COMPLETED
Registry status
Phase 3
Development phase
73 participants
Enrollment target

Study Summary

To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Primary Outcome

Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ

Interventions

  • DRUG Prochymal®

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2010-11-29
Est. Completion 2014-09-15
Phase Phase 3
Mesoblast

25 total trials

What the finished NCT01233960 record still lists

NCT01233960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 1 intervention - of which Prochymal® is the first listed.

NCT01233960 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01233960 about?

NCT01233960 is a clinical study titled "Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease". To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.

What is the current status of trial NCT01233960?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 73 participants. The study started on 2010-11-29. Estimated completion is 2014-09-15.

What interventions are being tested in trial NCT01233960?

The interventions under investigation include: Prochymal® (DRUG).

Who is sponsoring clinical trial NCT01233960?

This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01233960's enrollment target sits among peer trials

73 1780th of 2000 higher than 221 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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Source: ClinicalTrials.gov NCT01233960, the US trial registry maintained by the National Library of Medicine. NCT01233960 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.