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Rituximab to Treat Severe Hemophilia A (RICH)

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ClinicalTrials.gov Identifier: NCT00331006
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : June 11, 2013
Last Update Posted : June 11, 2013
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Genentech, Inc.
Information provided by (Responsible Party):
New England Research Institutes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hemophilia A
Intervention: Drug: Rituximab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at clinical sites and Hemophilia Treatment Centers participating in the study. The recruitment period began in August 2006 and continued through November 2011.

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

Reporting Groups
  Description
Rituximab Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks

Participant Flow for 4 periods

Period 1:   Screening Phase
    Rituximab
STARTED   23 
COMPLETED   16 [1] 
NOT COMPLETED   7 
Withdrawal by Subject                1 
enrollment halted                1 
Lost to Follow-up                1 
Ineligible for treatment phase                4 
[1] subjects eligible for the treatment phase if inhibitor titer following Factor VIII was at least 5 BU

Period 2:   Treatment Phase
    Rituximab
STARTED   16 
COMPLETED   15 
NOT COMPLETED   1 
Withdrawal by Subject                1 

Period 3:   Follow-Up Phase I
    Rituximab
STARTED   15 
COMPLETED   14 
NOT COMPLETED   1 
Lost to Follow-up                1 

Period 4:   Follow-Up Phase II
    Rituximab
STARTED   14 
COMPLETED   11 
NOT COMPLETED   3 
Lost to Follow-up                3 



  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.
All subjects who began the screening phase

Reporting Groups
  Description
Rituximab Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks

Baseline Measures
   Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Participants]
 
<=18 years   19 
Between 18 and 65 years   4 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.85  (12.02) 
Gender 
[Units: Participants]
 
Female   0 
Male   23 
Region of Enrollment 
[Units: Participants]
 
United States   23 


  Outcome Measures

1.  Primary:   Proportion of Subjects With Major Response, i.e. Inhibitor Level Falls to Less Than 5 BU/mL Between Weeks 6 to 22 and Remains Below 5 BU/mL at 5-7 Days Following Re-challenge With FVIII   [ Time Frame: Measured within approximately 22 weeks ]

2.  Secondary:   Proportion of Subjects With at Least Minor Response, i.e. Inhibitor Level Falls to <5 BU/mL Between Weeks 6-22 and Either Remains <5 BU/mL 5-7 Days Following FVIII Rechallenge or Titer Following FVIII Rechallenge is 5-10 BU/mL & <50% of Original Peak   [ Time Frame: Measured within approximately 22 weeks ]

3.  Secondary:   Percent Change in Inhibitor Titer on Challenge With Factor VIII From Baseline Challenge to Post-treatment Challenge   [ Time Frame: Measured within approximately 22 weeks ]

4.  Secondary:   Median Number of Bleeding Events Per Subject Meeting the Criteria of a Serious Adverse Event   [ Time Frame: Measured through Week 100 ]

5.  Secondary:   Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event   [ Time Frame: Measured through Week 100 ]

6.  Secondary:   Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events   [ Time Frame: Measured through Week 100 ]

7.  Secondary:   Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event   [ Time Frame: Measured through Week 100 ]

8.  Secondary:   Proportion of Rituximab Infusions in Which a Reaction to the Infusion Was Reported   [ Time Frame: Measured at Week 1 through Week 4 ]


  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
The study was terminated before reaching its target sample size of 50 subjects due to low enrollment rates. Therefore, confidence intervals for proportions are wide.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Susan F. Assmann, PhD
Organization: New England Research Institutes, Inc.
phone: 617-972-3048
e-mail: sassmann@neriscience.com



Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00331006     History of Changes
Other Study ID Numbers: 374
U01HL072268 ( U.S. NIH Grant/Contract )
U01HL072274 ( U.S. NIH Grant/Contract )
U01HL072290 ( U.S. NIH Grant/Contract )
U01HL072033 ( U.S. NIH Grant/Contract )
U01HL072291 ( U.S. NIH Grant/Contract )
U01HL072248 ( U.S. NIH Grant/Contract )
U01HL072355 ( U.S. NIH Grant/Contract )
U01HL072283 ( U.S. NIH Grant/Contract )
U01HL072346 ( U.S. NIH Grant/Contract )
U01HL072331 ( U.S. NIH Grant/Contract )
First Submitted: May 26, 2006
First Posted: May 29, 2006
Results First Submitted: January 7, 2013
Results First Posted: June 11, 2013
Last Update Posted: June 11, 2013