Phase II Study of HMPL-004 in Subjects With Crohn's Disease

This study has been completed.
Information provided by (Responsible Party):
Hutchison Medipharma Limited Identifier:
First received: April 6, 2008
Last updated: November 4, 2012
Last verified: November 2012
Results First Received: April 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: HMPL004
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
HMPL004 HMPL004 1200mg/d
Placebo Placebo

Participant Flow:   Overall Study
    HMPL004     Placebo  
STARTED     51     50  
COMPLETED     44     42  
NOT COMPLETED     7     8  
Lost to Follow-up                 2                 2  
Adverse Event                 2                 2  
Withdrawal by Subject                 3                 3  
Physician Decision                 0                 1  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
HMPL004 HMPL004 1200mg/d
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    HMPL004     Placebo     Total  
Number of Participants  
[units: participants]
  51     50     101  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     49     44     93  
>=65 years     2     6     8  
[units: years]
Mean (Standard Deviation)
  42.4  (13.4)     46.5  (14.2)     44.4  (13.9)  
[units: participants]
Female     28     29     57  
Male     23     21     44  
Region of Enrollment  
[units: participants]
United States     38     35     73  
Ukraine     13     15     28  

  Outcome Measures

1.  Primary:   The Efficacy of HMPL 004 Given at 1200 mg/Day, Assessed After 8 Weeks of Treatment With HMPL-004 in Inducing a Drop in the Subject's Crohn's Disease Activity Index (CDAI) by 100 Points.   [ Time Frame: 8 weeks ]

2.  Secondary:   Safety   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Hua Mu,Senior Vice President of Clinical Research and Development
Organization: Hutchison MediPharma
phone: 861 3564487805

Responsible Party: Hutchison Medipharma Limited Identifier: NCT00655733     History of Changes
Other Study ID Numbers: 200500401
Study First Received: April 6, 2008
Results First Received: April 18, 2011
Last Updated: November 4, 2012
Health Authority: United States: Food and Drug Administration