ClinicalTrials.gov
ClinicalTrials.gov Menu

Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis

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.
ClinicalTrials.gov Identifier: NCT00029107
Recruitment Status : Completed
First Posted : January 7, 2002
Results First Posted : April 3, 2012
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Michael C Sneller, MD, National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hepatitis C
Vasculitis
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
Between June 2002 and April 2010, a total of 24 patients were enrolled in the study. Twelve patients randomized to the rituximab group and 12 patients to the control group.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 47 patients were screened for randomization into this study. Eighteen patients did not meet one or more of the above eligibility criteria. Five eligible patients elected not to enroll in the study because of concerns about potential rituximab toxicity. The remaining 24 patients were enrolled in the study and underwent randomization

Reporting Groups
  Description
Immediate Treatment Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
Standard Therapy Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.

Participant Flow:   Overall Study
    Immediate Treatment   Standard Therapy
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Immediate Treatment Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
Standard Therapy Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
Total Total of all reporting groups

Baseline Measures
   Immediate Treatment   Standard Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   12   24 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (5.6)   51  (4)   51  (4.8) 
Gender 
[Units: Participants]
     
Female   2   4   6 
Male   10   8   18 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

1.  Primary:   Percent of Patients in Remission   [ Time Frame: month 6 ]


  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 not blinded. In addition, the study was limited to patients who had failed antiviral therapy.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael C Sneller, MD
Organization: NIAID/NIH
phone: 301-496-0491
e-mail: msneller@niaid.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael C Sneller, MD, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00029107     History of Changes
Other Study ID Numbers: 020096
02-I-0096 ( Other Identifier: NIAID Intramural protocol number )
First Submitted: January 5, 2002
First Posted: January 7, 2002
Results First Submitted: October 26, 2011
Results First Posted: April 3, 2012
Last Update Posted: April 16, 2012