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Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis

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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
Enrollment 47
Recruitment Details 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 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
Arm/Group Title Immediate Treatment Standard Therapy
Hide Arm/Group Description Patients receive treatment with four weekly infusions of rituximab immediately following randomization. Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Immediate Treatment Standard Therapy Total
Hide Arm/Group Description Patients receive treatment with four weekly infusions of rituximab immediately following randomization. Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab. Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
52  (5.6) 51  (4) 51  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
2
  16.7%
4
  33.3%
6
  25.0%
Male
10
  83.3%
8
  66.7%
18
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Percent of Patients in Remission
Hide Description The primary endpoint was the difference in rate of remission between the 2 arms at 6 months from study entry.
Time Frame month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Treatment Standard Therapy
Hide Arm/Group Description:
Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
83
(52 to 98)
8
(2 to 38)
Time Frame 6 months
Adverse Event Reporting Description Only adverse events that were grade 3 or greater and were possibly or probably related to the study drug were collected and analyzed for the purposes of this study
 
Arm/Group Title Immediate Treatment Standard Therapy
Hide Arm/Group Description Patients receive treatment with four weekly infusions of rituximab immediately following randomization. Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
All-Cause Mortality
Immediate Treatment Standard Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Immediate Treatment Standard Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/12 (50.00%)      8/12 (66.67%)    
Blood and lymphatic system disorders     
Leukopenia   1/12 (8.33%)  1 2/12 (16.67%)  2
thrombocytopenia   1/12 (8.33%)  1 1/12 (8.33%)  1
Hepatobiliary disorders     
AST elevation > grade 3   3/12 (25.00%)  4 3/12 (25.00%)  3
Infections and infestations     
Infection   1/12 (8.33%)  1 2/12 (16.67%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immediate Treatment Standard Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
The study was not blinded. In addition, the study was limited to patients who had failed antiviral therapy.
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
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