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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00655733
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : December 3, 2012
Last Update Posted : December 3, 2012
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: HMPL004
Drug: Placebo

  Participant Flow

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
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Reporting Groups
HMPL004 HMPL004 1200mg/d
Placebo Placebo

Participant Flow:   Overall Study
    HMPL004   Placebo
STARTED   51   50 
COMPLETED   44   42 
Lost to Follow-up                2                2 
Adverse Event                2                2 
Withdrawal by Subject                3                3 
Physician Decision                0                1 

  Baseline Characteristics

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

Baseline Measures
   HMPL004   Placebo   Total 
Overall Participants Analyzed 
[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.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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
First Submitted: April 6, 2008
First Posted: April 10, 2008
Results First Submitted: April 18, 2011
Results First Posted: December 3, 2012
Last Update Posted: December 3, 2012