Trial Outcomes & Findings for Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus (NCT NCT01222078)
NCT ID: NCT01222078
Last Updated: 2020-10-30
Results Overview
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Study was early terminated and participant withdrew on study Day 164.
TERMINATED
PHASE2
1 participants
Up to Month 24
2020-10-30
Participant Flow
The study was conducted at one site in France during the period 22 November 2010 to 19 May 2011 and was planned to enroll 8 participants. But only one participant was enrolled and received a single course of study medication. No participants were re-dosed.
Participant milestones
| Measure |
Otelixizumab
Participant received a single dose of otelixizumab intravenous (IV) infusions each given over a 30 minute period on 8 consecutive days in order: 0.1 milligrams (mg), 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before start of infusion (SOI), 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Otelixizumab
Participant received a single dose of otelixizumab intravenous (IV) infusions each given over a 30 minute period on 8 consecutive days in order: 0.1 milligrams (mg), 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before start of infusion (SOI), 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
|
Overall Study
Early termination of the study
|
1
|
Baseline Characteristics
Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
|
Age, Continuous
|
31 Years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 24Population: Safety Population consisted of participants who had received at least one dose of infusion.
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Study was early terminated and participant withdrew on study Day 164.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
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Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
Any AEs
|
1 Participants
|
|
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
Any SAEs
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Blood pressure was assessed at sitting position at Baseline and 1 to 7 hours of post-infusion of first treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Respiration rate was assessed at sitting position at Baseline and post-treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Temperature was recorded at sitting position at Baseline and post treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Heart rate was recorded at sitting position at Baseline and post-treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Month 24Population: Safety Population
Vital included assessment of SBP, DBP, respiration rate, heart rate and temperature were assessed at sitting position. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
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Number of Participants With Values Outside the Normal Range for Vitals
SBP and DBP
|
1 Participants
|
|
Number of Participants With Values Outside the Normal Range for Vitals
Respiration rate
|
1 Participants
|
|
Number of Participants With Values Outside the Normal Range for Vitals
Heart rate
|
1 Participants
|
|
Number of Participants With Values Outside the Normal Range for Vitals
Temperature
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Month 24Population: Safety Population
Levels of EBV were assessed periodically using Quantitative Polymerase Chain Reaction. If a participant had an EBV viral load of \>=10,000 copies per 10\^6 Peripheral Blood Mononuclear Cells (PBMCs) at any visit, the test was repeated as soon as possible to confirm this result. If the result was confirmed, the test was repeated weekly for 2 weeks or until the count decreases to \< 10,000 copies per 10\^6 PBMCs, whichever was longer. The EBV Load remained zero throughout the study. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination. The viral load was to measure using unit copies per 10\^6 Peripheral Blood Mononuclear Cells (PBMCs)
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
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Mean Epstein-Barr Virus (EBV) Viral Load
|
0 Copies per 10^6 PBMCs
Standard Deviation NA
The value remained zero throughout the study
|
PRIMARY outcome
Timeframe: Baseline and up to Month 24Population: Safety Population. Because of the early termination of the study this endpoint was not collected.
Total lymphocyte count was planned to be analyzed up to Month 24.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 1, 4 and 8 of each treatment coursePopulation: Safety Population
CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
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Mean Change in CD4+ and CD8+ T-cell Counts
|
NA Percent total lymphocytes
Standard Deviation NA
As study was early terminated, data was not analyzed
|
PRIMARY outcome
Timeframe: Days 1, 4 and 8 of each treatment coursePopulation: Safety Population
Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
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Mean Change in Circulating Peripheral T Lymphocytes
|
NA GI/L
Standard Deviation NA
As study was early terminated, data was not analyzed.
|
PRIMARY outcome
Timeframe: Days 1, 4 and 8 of each treatment coursePopulation: Safety Population
Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
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Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts
|
NA Percent total lymphocytes
Standard Deviation NA
As study was early terminated, data was not analyzed
|
PRIMARY outcome
Timeframe: Up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Month 24Population: Safety Population. Because of the early termination of the study the data was not collected.
Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, 4 and 8 of each treatment coursePopulation: Safety Population
Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
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Mean Circulating Peripheral T Lymphocytes Count
|
NA GI/L
Standard Deviation NA
As study was early terminated, data was not analyzed
|
SECONDARY outcome
Timeframe: Days 1, 4 and 8 of each treatment coursePopulation: Safety Population
Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
|
Mean Circulating CD4+ and CD8+ Subset Counts
|
NA Percent total lymphocytes
Standard Deviation NA
As study was early terminated, data was not analyzed
|
SECONDARY outcome
Timeframe: Days 1, 4 and 8 of each treatment coursePopulation: Safety Population
Assessment of CD3 antigen was planned to be done on Day 1, 4 and 8 of first treatment course. The data was planned to be presented with unit Molecules of Equivalent Soluble Fluorochrome (MESF). Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
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|---|---|
|
Mean Saturation of CD3 Antigen on Peripheral Blood T Cells
|
NA MESF
Standard Deviation NA
As study was early terminated, data was not analyzed
|
SECONDARY outcome
Timeframe: Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment coursePopulation: Safety Population
Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
|
|---|---|
|
Mean Individual Serum Concentrations of Otelixizumab
|
NA Nanograms per milliliter (ng/mL)
Standard Deviation NA
As study was early terminated, data was not analyzed
|
SECONDARY outcome
Timeframe: Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment coursePopulation: Safety Population
Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
|
|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Otelixizumab
|
NA ng/mL
Standard Deviation NA
As study was early terminated, data was not analyzed
|
SECONDARY outcome
Timeframe: Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment coursePopulation: Safety Population
Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
|
|---|---|
|
Time to Cmax (Tmax) of Otelixizumab
|
NA hours
Value could not be determined due to insufficient quantifiable concentrations and the study was early terminated.
|
SECONDARY outcome
Timeframe: Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment coursePopulation: Safety Population
Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
|
|---|---|
|
Area Under the Serum Concentration-time Curve [AUC(0-tlast)] of Otelixizumab
|
NA Hours times nanograms per milliliter
Standard Deviation NA
Value could not be determined due to insufficient quantifiable concentrations and the study was early terminated.
|
SECONDARY outcome
Timeframe: Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment coursePopulation: Safety Population
Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
|
|---|---|
|
Time of Last Observed Quantifiable Concentration (Tlast) of Otelixizumab
|
NA hours
Value could not be determined due to insufficient quantifiable concentrations and the study was early terminated.
|
SECONDARY outcome
Timeframe: Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment coursePopulation: Safety Population
Because of the early termination of the study the data was not analyzed.
Outcome measures
| Measure |
Otelixizumab
n=1 Participants
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
|
|---|---|
|
Terminal Phase Half-life (Thalf) of Otelixizumab
|
NA hours
Value could not be determined due to insufficient quantifiable concentrations and the study was early terminated.
|
Adverse Events
Otelixizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Otelixizumab
n=1 participants at risk
Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • All AEs and SAEs were reported since first dose of investigational product up to Month 24.
Safety Population consisted of participants who had received at least one dose of infusion.
|
|
Gastrointestinal disorders
Dyspepsia
|
100.0%
1/1 • All AEs and SAEs were reported since first dose of investigational product up to Month 24.
Safety Population consisted of participants who had received at least one dose of infusion.
|
|
General disorders
Pyrexia
|
100.0%
1/1 • All AEs and SAEs were reported since first dose of investigational product up to Month 24.
Safety Population consisted of participants who had received at least one dose of infusion.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • All AEs and SAEs were reported since first dose of investigational product up to Month 24.
Safety Population consisted of participants who had received at least one dose of infusion.
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Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER