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NCT01882764 · ClinicalTrials.gov registry record · Phase 3
HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis
A Phase 3 study, sponsored by Hutchison Medipharma Limited.
- Terminated
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
NCT01882764: Clinical Trial Phase 3 study, sponsored by Hutchison Medipharma Limited.
NCT01882764 is a Phase 3 study that was terminated before completion, run by Hutchison Medipharma Limited. The registered enrollment target is 66 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.
The verdict
NCT01882764, a Phase 3 study, was terminated before completion, sponsored by Hutchison Medipharma Limited.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
Study Summary
A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. Subjects are required to be in clinical remission or clinical response to enter the year long maintenance phase. This study will help evaluate if HMPL-004 is effective in subjects maintaining clinical remission following successful induction therapy achieving clinical remission or clinical response.
Primary Outcome
Clinical remission is defined as a modified Mayo Score ≤2 along with no individual score \>1 AND rectal bleeding score = 0.
Interventions
- DRUG Placebo
- DRUG HMPL-004
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
Why NCT01882764 stopped before completion
NCT01882764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 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 2 interventions - of which Placebo is the first listed.
NCT01882764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01882764 about?
NCT01882764 is a clinical study titled "HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis". A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication...
What is the current status of trial NCT01882764?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2013-06. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01882764?
The interventions under investigation include: Placebo (DRUG), HMPL-004 (DRUG).
Who is sponsoring clinical trial NCT01882764?
This trial is sponsored by Hutchison Medipharma Limited, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01882764's enrollment target sits among peer trials
66 1797th of 2000 higher than 204 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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