Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00029107
Status:
COMPLETED
Last Update Posted:
2012-04-16
First Post:
2002-01-05
Brief Title:
Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Rituximab Anti-CD20 for the Treatment of Hepatitis C Associated Cryoglobulinemic Vasculitis
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the efficacy of Rituximab anti-CD20 in the treatment of patients with hepatitis C associated cryoglobulinemic vasculitis HCV-CV who have failed or are intolerant to interferon-alpharibavirin therapy Up to 75 patients may be screened to enroll 34 adult patients with active HCV-CV in this randomized non-blinded phase III trial Patients will be randomized to receive either Rituximab 375 mgM2 on days 1 8 15 and 22 beginning at the time of enrollment or standard therapy Patients in both groups will be maintained on stable doses of any immunosuppressive therapies that they were receiving at the time of enrollment Response to Rituximab will be assessed by clinical and laboratory parameters
Although the cause of cryoglobulinemic vasculitis is not known a critical component is the presence of cryoglobulins-abnormal proteins that white blood cells called B lymphocytes produce in response to the chronic hepatitis C infection Rituximab decreases the number of B cells The Food and Drug Administration approved Rituximab in 1997 for the treatment of B-cell non-Hodgkins lymphoma
Patients between 18 and 75 years of age with hepatitis C and signs and symptoms of cryoglobulinemic vasculitis may be eligible for this study They must have failed or been unable to tolerate treatment with IFN-a and ribavirin Candidates will be screened with a history and physical examination electrocardiogram ECG blood and urine tests 24-hour urine collection and chest X-ray if clinically indicated
Participants will be randomly assigned to receive Rituximab upon entering the study or 6 months after entering the study Those whose treatment is delayed 6 months will be followed once a month at NIH for disease evaluation and blood tests during that time
Patients will be given Rituximab intravenously through a vein once a week for 4 weeks For the first dose patients will be admitted to the hospital for at least 24 hours after the infusion for monitoring Subsequent infusions will be given on an inpatient or outpatient basis depending on how the infusion is tolerated The day before each infusion they will have a history and physical examination blood work and other tests such as X-rays as clinically indicated
After the four infusions patients will be followed for drug side effects and response to treatment They will have blood tests every week for 4 weeks and will then return to NIH for 1 day every month for 12 months for a physical examination blood tests and X-rays if medically indicated Visits may be more frequent if necessary and patients may be asked to stay longer than a day if test findings requ
Although the cause of cryoglobulinemic vasculitis is not known a critical component is the presence of cryoglobulins-abnormal proteins that white blood cells called B lymphocytes produce in response to the chronic hepatitis C infection Rituximab decreases the number of B cells The Food and Drug Administration approved Rituximab in 1997 for the treatment of B-cell non-Hodgkins lymphoma
Patients between 18 and 75 years of age with hepatitis C and signs and symptoms of cryoglobulinemic vasculitis may be eligible for this study They must have failed or been unable to tolerate treatment with IFN-a and ribavirin Candidates will be screened with a history and physical examination electrocardiogram ECG blood and urine tests 24-hour urine collection and chest X-ray if clinically indicated
Participants will be randomly assigned to receive Rituximab upon entering the study or 6 months after entering the study Those whose treatment is delayed 6 months will be followed once a month at NIH for disease evaluation and blood tests during that time
Patients will be given Rituximab intravenously through a vein once a week for 4 weeks For the first dose patients will be admitted to the hospital for at least 24 hours after the infusion for monitoring Subsequent infusions will be given on an inpatient or outpatient basis depending on how the infusion is tolerated The day before each infusion they will have a history and physical examination blood work and other tests such as X-rays as clinically indicated
After the four infusions patients will be followed for drug side effects and response to treatment They will have blood tests every week for 4 weeks and will then return to NIH for 1 day every month for 12 months for a physical examination blood tests and X-rays if medically indicated Visits may be more frequent if necessary and patients may be asked to stay longer than a day if test findings requ
Detailed Description:
Although the cause of cryoglobulinemic vasculitis is not known a critical component is the presence of cryoglobulins-abnormal proteins that white blood cells called B lymphocytes produce in response to the chronic hepatitis C infection Rituximab decreases the number of B cells The Food and Drug Administration approved Rituximab in 1997 for the treatment of B-cell non-Hodgkins lymphoma
Patients between 18 and 75 years of age with hepatitis C and signs and symptoms of cryoglobulinemic vasculitis may be eligible for this study They must have failed or been unable to tolerate treatment with IFN-a and ribavirin Candidates will be screened with a history and physical examination electrocardiogram ECG blood and urine tests 24-hour urine collection and chest X-ray if clinically indicated
Participants will be randomly assigned to receive Rituximab or standard therapy for 6 months after entering the study All patients will be followed once a month at NIH for disease evaluation and blood tests during that time
Patients will be given Rituximab 375 mgm2intravenously once a week for 4 weeks The day before each infusion they will have a history and physical examination blood work and other tests such as X-rays as clinically indicated
After the four infusions patients will be followed for drug side effects and response to treatment They will have blood tests every week for 4 weeks and will then return to NIH for 1 day every month for 12 months for a physical examination blood tests and X-rays if medically indicated Visits may be more frequent if necessary
Patients between 18 and 75 years of age with hepatitis C and signs and symptoms of cryoglobulinemic vasculitis may be eligible for this study They must have failed or been unable to tolerate treatment with IFN-a and ribavirin Candidates will be screened with a history and physical examination electrocardiogram ECG blood and urine tests 24-hour urine collection and chest X-ray if clinically indicated
Participants will be randomly assigned to receive Rituximab or standard therapy for 6 months after entering the study All patients will be followed once a month at NIH for disease evaluation and blood tests during that time
Patients will be given Rituximab 375 mgm2intravenously once a week for 4 weeks The day before each infusion they will have a history and physical examination blood work and other tests such as X-rays as clinically indicated
After the four infusions patients will be followed for drug side effects and response to treatment They will have blood tests every week for 4 weeks and will then return to NIH for 1 day every month for 12 months for a physical examination blood tests and X-rays if medically indicated Visits may be more frequent if necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-I-0096 | OTHER | NIAID Intramural protocol number | None |