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NCT01805791 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis
A Phase 3 study, sponsored by Hutchison Medipharma Limited.
- Terminated
- Registry status
- Phase 3
- Development phase
- 201
- Enrollment target
NCT01805791: Clinical Trial Phase 3 study, sponsored by Hutchison Medipharma Limited.
NCT01805791 is a Phase 3 study that was terminated before completion, run by Hutchison Medipharma Limited. The registered enrollment target is 201 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805791, a Phase 3 study, was terminated before completion, sponsored by Hutchison Medipharma Limited.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 201 participants
- Enrollment target
Study Summary
A placebo controlled study of two doses of HMPL-004 in patients 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. The objective is to evaluate the efficacy and safety of HMPL-004 with mesalamine (mesalamine treatment failures). Efficacy will be measured by a comparison of the proportion of patients in each treatment group attaining clinical remission at Week 8 as compared to placebo.
Primary Outcome
Clinical remission was defined as a total Mayo Score of ≤2 points with no individual sub-score \>1 point and rectal bleeding score = 0.
Interventions
- DRUG Placebo
- DRUG HMPL-004 1800 mg/day
- DRUG HMPL-004 2400 mg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
Why NCT01805791 stopped before completion
NCT01805791 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01805791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01805791 about?
NCT01805791 is a clinical study titled "A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis". A placebo controlled study of two doses of HMPL-004 in patients 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. The objective is to evaluate the efficacy and safety...
What is the current status of trial NCT01805791?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2013-03. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01805791?
The interventions under investigation include: Placebo (DRUG), HMPL-004 1800 mg/day (DRUG), HMPL-004 2400 mg/day (DRUG).
Who is sponsoring clinical trial NCT01805791?
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 NCT01805791's enrollment target sits among peer trials
201 1353rd of 2000 higher than 648 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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