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Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01222078
Recruitment Status : Terminated (A Phase 3 study recently reported and demonstrated that the dose of otelixizumab in OTX113390 is not effective.)
First Posted : October 18, 2010
Results First Posted : June 16, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 1
Intervention: Biological: otelixizumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Otelixizumab
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Early termination of the study                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Otelixizumab 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.

Baseline Measures
   Otelixizumab 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 31 [1] 
[1] Only one participant enrolled
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      1 100.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)   [ Time Frame: Up to Month 24 ]

2.  Primary:   Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline and up to Month 24 ]

3.  Primary:   Mean Change From Baseline in Respiration Rate   [ Time Frame: Baseline and up to Month 24 ]

4.  Primary:   Mean Change From Baseline in Temperature   [ Time Frame: Baseline and up to Month 24 ]

5.  Primary:   Mean Change From Baseline in Heart Rate   [ Time Frame: Baseline and up to Month 24 ]

6.  Primary:   Number of Participants With Values Outside the Normal Range for Vitals   [ Time Frame: Up to Month 24 ]

7.  Primary:   Mean Change From Baseline in Value of Albumin and Total Protein   [ Time Frame: Baseline and up to Month 24 ]

8.  Primary:   Mean Change From Baseline in Value of Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Follicle Stimulating Hormone, Gamma Glutamyl Tranferase and Lactate Dehydrogenase   [ Time Frame: Baseline and up to Month 24 ]

9.  Primary:   Mean Change From Baseline in Value of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid   [ Time Frame: Baseline and up to Month 24 ]

10.  Primary:   Mean Change From Baseline in Value of Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen   [ Time Frame: Baseline and up to Month 24 ]

11.  Primary:   Mean Change From Baseline in Value of Estradiol   [ Time Frame: Baseline and up to Month 24 ]

12.  Primary:   Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and White Blood Cell Count   [ Time Frame: Baseline and up to Month 24 ]

13.  Primary:   Mean Change From Baseline in Glycosylated Hemoglobin Value   [ Time Frame: Baseline and up to Month 24 ]

14.  Primary:   Mean Change From Baseline in Hemoglobin Value   [ Time Frame: Baseline and up to Month 24 ]

15.  Primary:   Mean Change From Baseline in Red Blood Cell Count   [ Time Frame: Baseline and up to Month 24 ]

16.  Primary:   Mean Epstein-Barr Virus (EBV) Viral Load   [ Time Frame: Up to Month 24 ]

17.  Primary:   Mean Change in Total Lymphocyte Count   [ Time Frame: Baseline and up to Month 24 ]

18.  Primary:   Mean Change in CD4+ and CD8+ T-cell Counts   [ Time Frame: Days 1, 4 and 8 of each treatment course ]

19.  Primary:   Mean Change in Circulating Peripheral T Lymphocytes   [ Time Frame: Days 1, 4 and 8 of each treatment course ]

20.  Primary:   Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts   [ Time Frame: Days 1, 4 and 8 of each treatment course ]

21.  Primary:   Mean Serum Levels of Anti-otelixizumab Binding Antibodies   [ Time Frame: Up to Month 24 ]

22.  Primary:   Proportion of Anti-otelixizumab Neutralizing Antibodies   [ Time Frame: Up to Month 24 ]

23.  Secondary:   Mean Circulating Peripheral T Lymphocytes Count   [ Time Frame: Day 1, 4 and 8 of each treatment course ]

24.  Secondary:   Mean Circulating CD4+ and CD8+ Subset Counts   [ Time Frame: Days 1, 4 and 8 of each treatment course ]

25.  Secondary:   Mean Saturation of CD3 Antigen on Peripheral Blood T Cells   [ Time Frame: Days 1, 4 and 8 of each treatment course ]

26.  Secondary:   Mean Individual Serum Concentrations of Otelixizumab   [ Time Frame: 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 course ]

27.  Secondary:   Maximum Observed Serum Concentration (Cmax) of Otelixizumab   [ Time Frame: 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 course ]

28.  Secondary:   Time to Cmax (Tmax) of Otelixizumab   [ Time Frame: 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 course ]

29.  Secondary:   Area Under the Serum Concentration-time Curve [AUC(0-tlast)] of Otelixizumab   [ Time Frame: 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 course ]

30.  Secondary:   Time of Last Observed Quantifiable Concentration (Tlast) of Otelixizumab   [ Time Frame: 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 course ]

31.  Secondary:   Terminal Phase Half-life (Thalf) of Otelixizumab   [ Time Frame: 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 course ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01222078     History of Changes
Other Study ID Numbers: 113390
First Submitted: October 7, 2010
First Posted: October 18, 2010
Results First Submitted: April 3, 2017
Results First Posted: June 16, 2017
Last Update Posted: August 25, 2017