A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)

• Sponsor: CSL Behring (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00701662
• Collaborator: (none)
• Enrollment: 8
• Locations: 3
• Arm: 1
• Duration (Months): 14
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The objective of this study is to assess efficacy, safety, and convenience of purified human antibodies administered under the skin in the treatment of MMN patients.

Condition or Disease	Intervention/Treatment	Phase
Multifocal Motor Neuropathy (MMN)	Biological: Vivaglobin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicentre Study of Subcutaneous Immunoglobulin (SCIG) in Patients With Multifocal Motor Neuropathy (MMN)
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vivaglobin Vivaglobin® is a 16% (160 mg/mL) liquid formulation of human normal immunoglobulin for subcutaneous infusion. Subjects will receive weekly infusions of Vivaglobin® at a weekly dosage calculated based on previous intravenous immunoglobulin treatment (between 0.1 to 0.5 g/kg body weight per week).	Biological: Vivaglobin; Other Names: Human Normal Immunoglobulin

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Week 24 in Muscle Strength [Baseline to week 24]

   The change in Medical Research Council (MRC) score was determined at week 24 compared to baseline using descriptive statistics and nonparametric, two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available. The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline.

2. Mean Overall MRC Score at Baseline and Week 24 [Baseline and week 24]

   The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement.

Secondary Outcome Measures

1. Change From Baseline to Week 24 in Disability [Baseline to week 24]

   The change in disability score was determined at week 24 compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available. Disability was measured using a modified Guy's Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability. Negative values for change in disability score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline.

2. Mean Disability Score at Baseline and Week 24 [Baseline and Week 24]

   Disability was measured using a modified Guy's Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability.

3. Change From Baseline to the Completion Visit in Motor Function [Baseline to the completion visit (up to week 25)]

   The change in motor function was determined at the completion visit compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst). The baseline motor function score was calculated as the mean of the patient's assessments at Screening and Week 1. Negative values for change in motor function score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline.

4. Mean Motor Function Score at Screening and Week 25 [Screening and week 25]

   For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst).

5. Health-Related Quality of Life at Baseline and Week 25 [At baseline and week 25]

   Assessed using a questionnaire on patients' satisfaction with current immunoglobulin G (IgG) treatment, treatment at home, and treatment at the hospital/doctor's office. The questions were answered by choosing a number between 1 (extremely good) and 7 (extremely bad). Note: No patients received IgG treatment at the hospital/doctor's office at Week 25.

6. Treatment Satisfaction at Baseline and Week 25 [At baseline and week 25]

   Treatment satisfaction was assessed using the Life Quality Index, which comprises 15 items rated on a 7-point scale (1 = worst rating, 7 = best rating) with a possible maximum score of 105. The highest score indicates the highest satisfaction with the impact of treatment on social factors. The 15 items were summarized to 4 scales: treatment interference, therapy-related problems, therapy setting, and treatment costs. The raw scores for these scales were transformed to a score ranging from 0 to 100, with 100 being the best score achievable.

7. Overall Health Status at Baseline and Week 25 [Baseline and week 25]

   Overall Health Status was assessed using a Visual Analogue Scale (VAS). Patients were asked to rate their overall health status by placing a mark on a 100 mm VAS, with 0 being the worst imaginable state and 100 being the best imaginable state.

8. Number of Patients With Adverse Events (AEs) by Severity and Relatedness [For the duration of the study, up to Week 25]

   Included all AEs that occurred during the entire study period. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.

9. Rate of AEs by Severity and Relatedness [For the duration of the study, up to Week 25]

   The rate was the number of AEs over the number of infusions administered. Included all AEs that occurred during the entire study period. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.

10. Number of Patients With Local/Injection Site Reactions [For the duration of the study, up to Week 25]

    All AEs arising from local/injection site reactions.

11. Number of Patients With Clinically Relevant Changes in Laboratory Parameters [Baseline to Week 25]

    Laboratory parameters included hematology, serum chemistry, and urinalysis parameters.

12. Number of Patients With Clinically Relevant Changes in Vital Signs [Baseline to Week 25]

    Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with documented clinical diagnosis and electrophysiological evidence of MMN

• Patients who have previously responded to intravenous immunoglobulin (IVIG) and have been on stable treatment with IVIG for at least 12 weeks prior to screening

• Patients treated with the equivalent of ≥0.4g/kg body weight (bw) IVIG per month

• Provision of informed consent by patient

Exclusion Criteria:

• Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) concentration

2.5 times the upper normal limit (UNL)

• Creatinine concentration >1.5 times the UNL

• Known allergic reactions to blood products

• Any skin disease interfering with the assessment of injection site reactions

• Any other medical condition, which in the opinion of the investigator, might interfere with successful completion of the protocol

• Any condition likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial

• Participation in a study with an investigational drug within three months prior to enrolment

• Patients treated with the equivalent of >2.0g/kg bw IVIG per month

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Raffaele Hospital	Milan		Italy
2	Inselspital	Bern		Switzerland
3	Dept. Clinical Immunology, Oxford Radcliffe Hospitals	Oxford		United Kingdom

Sponsors and Collaborators

• CSL Behring

Investigators

• Principal Investigator: Matthias Sturzenegger, MD, Inselspital, University Hospital of Bern
• Principal Investigator: Bernd Kieseier, MD, Neurologische Klinik, Heinrich-Heine-University, Düsseldorf
• Principal Investigator: Giancarlo Comi, MD, San Raffaele Hospital
• Principal Investigator: Siraj Misbah, MD, Dept. Clinical Immunology, Oxford Radcliffe Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CSL Behring
• ClinicalTrials.gov Identifier: NCT00701662
• Other Study ID Numbers: 1464; ZLB06_006CR; 2007-000710-37
• First Posted: Jun 19, 2008
• Last Update Posted: Aug 1, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Neuritis; Immunoglobulins

Study Results

Participant Flow

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Period Title: Overall Study
STARTED	8
COMPLETED	7
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Overall Participants	8
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.3 (8.78)
Age, Customized (participants) [Number]
> 18 to < 65 years	5 62.5%
>= 65 years	3 37.5%
Sex: Female, Male (Count of Participants)
Female	4 50%
Male	4 50%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Week 24 in Muscle Strength
Description	The change in Medical Research Council (MRC) score was determined at week 24 compared to baseline using descriptive statistics and nonparametric, two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available. The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline.
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

The Intention-to-Treat (ITT) data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Mean (95% Confidence Interval) [score on a scale]	0.4 (5.07)

2. Secondary Outcome

Title	Change From Baseline to Week 24 in Disability
Description	The change in disability score was determined at week 24 compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available. Disability was measured using a modified Guy's Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability. Negative values for change in disability score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline.
Time Frame	Baseline to week 24

Outcome Measure Data

Analysis Population Description

The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Mean (95% Confidence Interval) [score on a scale]	0.1 (1.13)

3. Secondary Outcome

Title	Mean Disability Score at Baseline and Week 24
Description	Disability was measured using a modified Guy's Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Disability score at baseline (n = 8)	2.0
Disability score at week 24 (n = 7)	1.9

4. Secondary Outcome

Title	Change From Baseline to the Completion Visit in Motor Function
Description	The change in motor function was determined at the completion visit compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst). The baseline motor function score was calculated as the mean of the patient's assessments at Screening and Week 1. Negative values for change in motor function score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline.
Time Frame	Baseline to the completion visit (up to week 25)

Outcome Measure Data

Analysis Population Description

The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Mean (95% Confidence Interval) [score on a scale]	0.4 (1.94)

5. Primary Outcome

Title	Mean Overall MRC Score at Baseline and Week 24
Description	The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

The ITT data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
MRC score at baseline (n = 8)	178.3
MRC score at week 24 (n = 7)	184.3

6. Secondary Outcome

Title	Mean Motor Function Score at Screening and Week 25
Description	For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst).
Time Frame	Screening and week 25

Outcome Measure Data

Analysis Population Description

The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Motor function score at screening (n = 8)	5.5
Motor function score at week 25 (n = 7)	4.6

7. Secondary Outcome

Title	Health-Related Quality of Life at Baseline and Week 25
Description	Assessed using a questionnaire on patients' satisfaction with current immunoglobulin G (IgG) treatment, treatment at home, and treatment at the hospital/doctor's office. The questions were answered by choosing a number between 1 (extremely good) and 7 (extremely bad). Note: No patients received IgG treatment at the hospital/doctor's office at Week 25.
Time Frame	At baseline and week 25

Outcome Measure Data

Analysis Population Description

The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Current treatment, baseline (n = 8)	2.6 (1.06)
Current treatment, week 25 (n = 7)	1.3 (0.49)
At home, baseline (n = 3)	1.0 (0.00)
At home, week 25 (n = 7)	1.1 (0.38)
In the hospital/doctor's office, baseline (n = 7)	2.9 (1.57)

8. Secondary Outcome

Title	Treatment Satisfaction at Baseline and Week 25
Description	Treatment satisfaction was assessed using the Life Quality Index, which comprises 15 items rated on a 7-point scale (1 = worst rating, 7 = best rating) with a possible maximum score of 105. The highest score indicates the highest satisfaction with the impact of treatment on social factors. The 15 items were summarized to 4 scales: treatment interference, therapy-related problems, therapy setting, and treatment costs. The raw scores for these scales were transformed to a score ranging from 0 to 100, with 100 being the best score achievable.
Time Frame	At baseline and week 25

Outcome Measure Data

Analysis Population Description

The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Treatment interference, baseline (n = 8)	60.76 (25.827)
Treatment interference, week 25 (n = 6)	91.67 (9.780)
Therapy-related problems, baseline (n = 8)	70.30 (27.055)
Therapy-related problems, week 25 (n = 7)	89.29 (14.402)
Therapy setting, baseline (n = 8)	75.01 (33.844)
Therapy setting, week 25 (n = 6)	96.28 (6.743)
Treatment costs, baseline (n = 8)	70.84 (34.498)
Treatment costs, week 25 (n = 6)	86.10 (19.486)

9. Secondary Outcome

Title	Overall Health Status at Baseline and Week 25
Description	Overall Health Status was assessed using a Visual Analogue Scale (VAS). Patients were asked to rate their overall health status by placing a mark on a 100 mm VAS, with 0 being the worst imaginable state and 100 being the best imaginable state.
Time Frame	Baseline and week 25

Outcome Measure Data

Analysis Population Description

The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Baseline (n = 8)	72.1 (15.38)
Week 25 (n = 7)	73.9 (14.67)

10. Secondary Outcome

Title	Number of Patients With Adverse Events (AEs) by Severity and Relatedness
Description	Included all AEs that occurred during the entire study period. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Time Frame	For the duration of the study, up to Week 25

Outcome Measure Data

Analysis Population Description

The safety data set (SDS) comprised all treated patients.

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
All AEs	4 50%
Mild AEs	3 37.5%
Moderate AEs	2 25%
Severe AEs	0 0%
Not related AEs	4 50%
Possibly related AEs	0 0%
Probably related AEs	0 0%
Related AEs	1 12.5%

11. Secondary Outcome

Title	Rate of AEs by Severity and Relatedness
Description	The rate was the number of AEs over the number of infusions administered. Included all AEs that occurred during the entire study period. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Time Frame	For the duration of the study, up to Week 25

Outcome Measure Data

Analysis Population Description

The SDS comprised all treated patients.

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Measure Infusions	183
All AEs	0.104
Mild AEs	0.093
Moderate AEs	0.011
Severe AEs	0.000
Not related AEs	0.038
Possibly related AEs	0.000
Probably related AEs	0.000
Related AEs	0.066

12. Secondary Outcome

Title	Number of Patients With Local/Injection Site Reactions
Description	All AEs arising from local/injection site reactions.
Time Frame	For the duration of the study, up to Week 25

Outcome Measure Data

Analysis Population Description

The SDS comprised all treated patients.

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Total	1 12.5%
Injection site oedema	1 12.5%
Injection site pruritis	1 12.5%
Skin reaction	1 12.5%

13. Secondary Outcome

Title	Number of Patients With Clinically Relevant Changes in Laboratory Parameters
Description	Laboratory parameters included hematology, serum chemistry, and urinalysis parameters.
Time Frame	Baseline to Week 25

Outcome Measure Data

Analysis Population Description

The SDS comprised all treated patients.

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Number [participants]	0 0%

14. Secondary Outcome

Title	Number of Patients With Clinically Relevant Changes in Vital Signs
Description	Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.
Time Frame	Baseline to Week 25

Outcome Measure Data

Analysis Population Description

The SDS comprised all treated patients.

Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
Measure Participants	8
Number [participants]	0 0%

Adverse Events

Time Frame	For the duration of the study, up to Week 25.
Adverse Event Reporting Description	The SDS comprised all treated patients. "General disorders" were collected under the Medical Dictionary for Regulatory Activities System organ class (MedDRA SOC) General disorders and administration site conditions.
Arm/Group Title	Vivaglobin
Arm/Group Description	Human normal immunoglobulin, 0.1 to 0.5 g/kg body weight per week.
All Cause Mortality
	Vivaglobin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Vivaglobin
	Affected / at Risk (%)	# Events
Total	0/8 (0%)
Other (Not Including Serious) Adverse Events
	Vivaglobin
	Affected / at Risk (%)	# Events
Total	4/8 (50%)
Blood and lymphatic system disorders
Spontaneous haematoma	1/8 (12.5%)	1
General disorders
Asthenia	1/8 (12.5%)	1
Injection-site oedema	1/8 (12.5%)	4
Injection-site pruritus	1/8 (12.5%)	4
Infections and infestations
Influenza	1/8 (12.5%)	1
Orchitis	1/8 (12.5%)	1
Nervous system disorders
Hemicephalalgia	1/8 (12.5%)	1
Multifocal motor neuropathy	1/8 (12.5%)	1
Skin and subcutaneous tissue disorders
Erythema	1/8 (12.5%)	1
Skin reaction	1/8 (12.5%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.