Trial Outcomes & Findings for Rituximab to Treat Severe Hemophilia A (NCT NCT00331006)

Last Updated: 2013-06-11

Results Overview

Presence or absence of a major response in each participant. Major response is defined as occurring when 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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Measured within approximately 22 weeks

Results posted on

2013-06-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Rituximab Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Screening Phase STARTED	23
Screening Phase COMPLETED	16
Screening Phase NOT COMPLETED	7
Treatment Phase STARTED	16
Treatment Phase COMPLETED	15
Treatment Phase NOT COMPLETED	1
Follow-Up Phase I STARTED	15
Follow-Up Phase I COMPLETED	14
Follow-Up Phase I NOT COMPLETED	1
Follow-Up Phase II STARTED	14
Follow-Up Phase II COMPLETED	11
Follow-Up Phase II NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Screening Phase Withdrawal by Subject	1
Screening Phase enrollment halted	1
Screening Phase Lost to Follow-up	1
Screening Phase Ineligible for treatment phase	4
Treatment Phase Withdrawal by Subject	1
Follow-Up Phase I Lost to Follow-up	1
Follow-Up Phase II Lost to Follow-up	3

Baseline Characteristics

Rituximab to Treat Severe Hemophilia A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=23 Participants Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Age, Categorical <=18 years	19 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	15.85 years STANDARD_DEVIATION 12.02 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	23 Participants n=99 Participants
Region of Enrollment United States	23 participants n=99 Participants

PRIMARY outcome

Timeframe: Measured within approximately 22 weeks

Population: All participants who received at least one dose of rituximab

Outcome measures

Outcome measures
Measure	Rituximab n=16 Participants Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
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	.1875 proportion of participants Interval 0.053 to 1.0

SECONDARY outcome

Timeframe: Measured within approximately 22 weeks

Population: All participants who received at least one dose of rituximab

Presence or absence of at least a minor response in each participant

Outcome measures

Outcome measures
Measure	Rituximab n=16 Participants Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
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	0.25 proportion of participants Interval 0.073 to 0.524

SECONDARY outcome

Timeframe: Measured within approximately 22 weeks

Population: All subjects who received a post-treatment rechallenge and had at least a minor response.

percent change=100%\*(A-B)/B where A=inhibitor titer measured within 5-7 days following FVIII rechallenge and B=inhibitor titer measured within 5-14 days following baseline FVIII challenge. A FVIII rechallenge was performed within 10-18 days of the first monthly study visit in which an inhibitor titer result \<5 BU/mL was obtained beginning 2 weeks and continuing through 18 weeks following the last rituximab infusion.

Outcome measures

Outcome measures
Measure	Rituximab n=4 Participants Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Percent Change in Inhibitor Titer on Challenge With Factor VIII From Baseline Challenge to Post-treatment Challenge	-64.31 percentage change Interval -77.11 to -44.49

SECONDARY outcome

Timeframe: Measured through Week 100

Population: Data on bleeding events were collected at every study visit for all study participants. Data for this outcome was collected through the particpants end of study or Week 100, whichever came first, and is restricted to the 16 subjects who received at least one dose of rituximab.

Median number of bleeding events per subject meeting the criteria of a serious adverse event

Outcome measures

Outcome measures
Measure	Rituximab n=16 Participants Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Median Number of Bleeding Events Per Subject Meeting the Criteria of a Serious Adverse Event	0 participants Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Measured through Week 100

Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event

Outcome measures

Outcome measures
Measure	Rituximab n=16 Participants Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Median Number of Bleeding Events Per Subject Not Meeting the Criteria of a Serious Adverse Event	19.5 participants Interval 11.0 to 41.0

SECONDARY outcome

Timeframe: Measured through Week 100

Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events

Outcome measures

Outcome measures
Measure	Rituximab n=16 Participants Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Median Number of Serious Adverse Events Per Subject Other Than Bleeding Events	1 participants Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: Measured through Week 100

Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event

Outcome measures

Outcome measures
Measure	Rituximab n=16 Participants Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Median Number of Adverse Events Per Subject That Were Not Bleeding Events and Did Not Meet the Criteria of a Serious Adverse Event	1.5 participants Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Measured at Week 1 through Week 4

Population: All rituximab infusions given to study participants

Proportion of rituximab infusions in which a reaction to the infusion was reported

Outcome measures

Outcome measures
Measure	Rituximab n=61 rituximab infusions Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Proportion of Rituximab Infusions in Which a Reaction to the Infusion Was Reported	0.11 proportion of rituximab infusions Interval 0.05 to 0.22

Adverse Events

Rituximab

Serious events: 11 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab n=16 participants at risk Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Gastrointestinal disorders Diarrhea	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Gastrointestinal disorders Mallory-Weiss tear	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
General disorders Allergic reaction/hypersensitivity	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
General disorders Fever	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Central line infection	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Pulmonary/upper respiratory infection	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Sepsis	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Viral meningitis	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Zoster infection	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Bleeding and/or hematoma due to injury	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Bleeding and/or hematoma due to procedure complication	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Hematoma due to injury	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Hematoma due to procedure complication	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Joint and other bleeding due to injury	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Joint bleeding due to injury	18.8% 3/16 • Number of events 6 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Bleeding and/or hematoma - spontaneous	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Bone fracture	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Joint and other bleeding - spontaneous	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Joint bleeding - spontaneous	25.0% 4/16 • Number of events 11 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Joint bleeding due to procedure complication	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Nervous system disorders Headache	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Nervous system disorders Subdural hemorrhage	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Shortness of breath	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Surgical and medical procedures Port placement	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Surgical and medical procedures Port removal and replacement	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Surgical and medical procedures Synovectomy	12.5% 2/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Vascular disorders Hypotension	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Vascular disorders Splenic hematoma	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.

Other adverse events

Other adverse events
Measure	Rituximab n=16 participants at risk Rituximab administered at a dose of 375 mg/m\^2 by slow intravenous infusion once per week for 4 weeks
Blood and lymphatic system disorders Anemia	6.2% 1/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Blood and lymphatic system disorders Enlarged lymph nodes	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Blood and lymphatic system disorders Increased blood lymphocytes	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Blood and lymphatic system disorders Increased blood monocytes	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Blood and lymphatic system disorders Neutropenia	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Blood and lymphatic system disorders White blood cell decrease	6.2% 1/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Endocrine disorders Sweating	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Eye disorders Pink eye	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Gastrointestinal disorders Abdominal pain	12.5% 2/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Gastrointestinal disorders Bleeding - spontaneous	25.0% 4/16 • Number of events 12 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Gastrointestinal disorders Diarrhea	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Gastrointestinal disorders Heartburn	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Gastrointestinal disorders Toothache	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Number of events 4 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
General disorders Bleed and/or hematoma	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
General disorders Chills	18.8% 3/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
General disorders fatigue	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
General disorders Fever	12.5% 2/16 • Number of events 4 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
General disorders Lethargy	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Hepatobiliary disorders Decreased ALT	6.2% 1/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Hepatobiliary disorders Elevated ALT	6.2% 1/16 • Number of events 7 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Immune system disorders Allergy	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Cold sore	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Group A strep	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Influenza	12.5% 2/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Septic polyarthritis	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Infections and infestations Sinusitis	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Bleed and/or hematoma due to injury	25.0% 4/16 • Number of events 12 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Bleeding due to injury	18.8% 3/16 • Number of events 9 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Bleeding due to procedure complication	12.5% 2/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Head injury	12.5% 2/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Joint bleeding due to injury	68.8% 11/16 • Number of events 31 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Joint pain due to injury	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications vaccination site reaction	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Metabolism and nutrition disorders Anorexia	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Joint bleeding, spontaneous	93.8% 15/16 • Number of events 262 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Joint pain	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Joint pain, spontaneous	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	12.5% 2/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Muscle pain, spontaneous	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Pain	12.5% 2/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Bleed and/or hematoma - spontaneous	62.5% 10/16 • Number of events 26 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Nervous system disorders Bells palsy	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Nervous system disorders Bleeding - spontaneous	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Nervous system disorders Headache	12.5% 2/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Nervous system disorders Intolerance to light	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Renal and urinary disorders Bleeding - spontaneous	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Renal and urinary disorders Hematuria	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Asthma	6.2% 1/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Bleeding - spontaneous	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Reproductive system and breast disorders Cold	12.5% 2/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Elevated carbon dioxide in the blood	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Runny nose	12.5% 2/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Sore throat	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Respiratory, thoracic and mediastinal disorders Wheezing	6.2% 1/16 • Number of events 2 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Skin and subcutaneous tissue disorders Bleed and/or hematoma - spontaneous	43.8% 7/16 • Number of events 20 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Skin and subcutaneous tissue disorders Hematoma - spontaneous	56.2% 9/16 • Number of events 24 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Skin and subcutaneous tissue disorders Rash	12.5% 2/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Skin and subcutaneous tissue disorders Sunburn	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Vascular disorders High blood pressure	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Vascular disorders Low blood pressure	6.2% 1/16 • Number of events 4 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Vascular disorders Pulmonary hypertension	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Hematoma due to injury	37.5% 6/16 • Number of events 14 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Hematoma due to procedure complication	25.0% 4/16 • Number of events 5 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Injury, poisoning and procedural complications Pain	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Bleeding - spontaneous	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Musculoskeletal and connective tissue disorders Hematoma - spontaneous	18.8% 3/16 • Number of events 3 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.
Skin and subcutaneous tissue disorders Bleeding - spontaneous	6.2% 1/16 • Number of events 1 • Through week 100 Restricted to the 16 subjects who received at least one dose of rituximab.

Additional Information

Susan F. Assmann, PhD

New England Research Institutes, Inc.

Phone: 617-972-3048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Baxter donated Factor VIII and Genentech donated rituximab for the study. Both Baxter and Genentech can review results communications prior to public release for a period of time less than or equal to 60 days from the time submitted to them for review. These companies cannot require changes to the communication.
Publication restrictions are in place

Restriction type: OTHER