Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331006
Status:
COMPLETED
Last Update Posted:
2013-06-11
First Post:
2006-05-26
Brief Title:
Rituximab to Treat Severe Hemophilia A
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Rituximab for the Treatment of Inhibitors in Congenital Hemophilia A A TMH CTN Study
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RICH
Brief Summary:
Hemophilia A is a serious blood clotting disorder caused by a lack of factor VIII a specialized protein needed for normal blood clotting to occur Individuals with this disease may experience spontaneous bleeding pain and swelling in their joints due to excess bleeding and bruising A common treatment for severe hemophilia A is to intravenously replace the deficient blood clotting factor however some individuals may develop antibodies to this replacement factor This study will evaluate the effectiveness of rituximab at reducing the antibodies that develop in response to the replacement factor in individuals with severe hemophilia A
Detailed Description:
Hemophilia A is a hereditary blood clotting disorder It is caused by a deficiency or abnormality of the blood clotting protein factor VIII Individuals with hemophilia A are unable to form blood clots to stop bleeding and are at risk for experiencing serious and life-threatening bleeding episodes The most common treatment for this disease is intravenous replacement of factor VIII However between 30 to 40 of individuals eventually develop inhibitors or antibodies to the replacement factor In these individuals the immune system recognizes the replacement factor as foreign and attacks it thereby countering any potential benefits of the treatment Some individuals with severe hemophilia A may undergo immune tolerance therapy ITT in which they receive replacement factor on a regular basis as a way for the body to adjust to the factor and stop inhibitor production This treatment however is not always effective for everyone Preliminary research has shown that rituximab a medication used to treat non-Hodgkins lymphoma may be successful in suppressing or eliminating the inhibitors that develop The purpose of this study is to evaluate the effectiveness of rituximab at lowering the levels of factor VIII inhibitors in individuals with severe hemophilia A
This study will enroll individuals with severe hemophilia A At study entry participants will receive one intravenous dose of factor VIII Inhibitor levels will be measured with a blood test 5 to 7 days following this procedure If peak inhibitor level is above 5 Bethesda units BUmL 5 to 9 days later participants will begin receiving rituximab intravenously once a week for 4 weeks Blood will be collected at each visit for laboratory testing Two weeks following the last rituximab treatment participants will have blood drawn for inhibitor testing this testing will occur every 4 weeks through Week 22 If the participants inhibitor level falls below 5 BUmL participants will receive a repeat dose of factor VIII and blood will be drawn 5 to 7 days later for inhibitor testing Follow-up visits will occur at Weeks 36 52 and 100 and will include a physical examination blood collection and monitoring of bleeding events and infections Telephone interviews will be conduced at Weeks 64 76 and 88 to monitor bleeding events and infections
This study will enroll individuals with severe hemophilia A At study entry participants will receive one intravenous dose of factor VIII Inhibitor levels will be measured with a blood test 5 to 7 days following this procedure If peak inhibitor level is above 5 Bethesda units BUmL 5 to 9 days later participants will begin receiving rituximab intravenously once a week for 4 weeks Blood will be collected at each visit for laboratory testing Two weeks following the last rituximab treatment participants will have blood drawn for inhibitor testing this testing will occur every 4 weeks through Week 22 If the participants inhibitor level falls below 5 BUmL participants will receive a repeat dose of factor VIII and blood will be drawn 5 to 7 days later for inhibitor testing Follow-up visits will occur at Weeks 36 52 and 100 and will include a physical examination blood collection and monitoring of bleeding events and infections Telephone interviews will be conduced at Weeks 64 76 and 88 to monitor bleeding events and infections
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 |
|---|---|---|---|
| U01HL072331 | NIH | None | httpsreporternihgovquickSearchU01HL072331 |
| U01HL072268 | NIH | None | None |
| U01HL072274 | NIH | None | None |
| U01HL072290 | NIH | None | None |
| U01HL072033 | NIH | None | None |
| U01HL072291 | NIH | None | None |
| U01HL072248 | NIH | None | None |
| U01HL072355 | NIH | None | None |
| U01HL072283 | NIH | None | None |
| U01HL072346 | NIH | None | None |