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Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01014988
First received: November 16, 2009
Last updated: February 8, 2017
Last verified: January 2017
Results First Received: February 8, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Influenza, Human
Intervention: Drug: zanamivir aqueous solution

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Male or female participants who were >=6 months of age, hospitalized with laboratory-confirmed influenza, and able to receive study drug within 7 days of influenza symptom onset were enrolled in the study.

Reporting Groups
  Description
Cohort 6: Adults (18 Years and Older) Participants >=18 years of age received 600 milligrams (mg) zanamivir by intravenous (IV) infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.

Participant Flow:   Overall Study
    Cohort 6: Adults (18 Years and Older)   Cohort 1: Infants (6 Months to <1 Year of Age)   Cohort 2: Children (1 to <2 Years of Age)   Cohort 3: Children (2 to <6 Years of Age)   Cohort 4: Children (6 to <13 Years of Age)   Cohort 5: Adolescents (13 to <18 Years of Age)
STARTED   130   7   11   12   27   14 
COMPLETED   107   7   9   12   26   11 
NOT COMPLETED   23   0   2   0   1   3 
Adverse Event                20                0                1                0                1                3 
Lost to Follow-up                1                0                1                0                0                0 
Physician Decision                1                0                0                0                0                0 
Withdrawal by Subject                1                0                0                0                0                0 



  Baseline Characteristics
  Hide 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
Cohort 6: Adults (18 Years and Older) Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 1: Infants (6 Months to <1 Year of Age) Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 2: Children (1 to <2 Years of Age) Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 3: Children (2 to <6 Years of Age) Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 4: Children (6 to <13 Years of Age) Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Cohort 5: Adolescents (13 to <18 Years of Age) Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
Total Total of all reporting groups

Baseline Measures
   Cohort 6: Adults (18 Years and Older)   Cohort 1: Infants (6 Months to <1 Year of Age)   Cohort 2: Children (1 to <2 Years of Age)   Cohort 3: Children (2 to <6 Years of Age)   Cohort 4: Children (6 to <13 Years of Age)   Cohort 5: Adolescents (13 to <18 Years of Age)   Total 
Overall Participants Analyzed 
[Units: Participants]
 130   7   11   12   27   14   201 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.30  (16.19)   0.76  (0.127)   1.33  (0.220)   3.74  (1.201)   8.67  (1.861)   15.36  (1.151)   33.81  (23.796) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      56  43.1%      1  14.3%      4  36.4%      4  33.3%      9  33.3%      6  42.9%      80  39.8% 
Male      74  56.9%      6  85.7%      7  63.6%      8  66.7%      18  66.7%      8  57.1%      121  60.2% 
Race/Ethnicity, Customized 
[Units: Participants]
             
African American/African Heritage   10   1   4   1   4   3   23 
American Indian or Alaska Native   1   0   0   0   0   0   1 
Asian - East Asian Heritage   4   0   0   0   0   0   4 
Asian - South East Asian Heritage   10   0   0   0   0   0   10 
Asian - Japanese Heritage   0   1   0   2   0   0   3 
Native Hawaiian or Other Pacific Islander   0   0   0   0   1   0   1 
White - Arabic/North African Heritage   6   0   0   1   1   0   8 
White - White/Caucasian/European Heritage   97   5   7   7   18   11   145 
Unknown   2   0   0   0   1   0   3 
Mixed Race   0   0   0   1   2   0   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment   [ Time Frame: Up to post-treatment (PT) + 23 days ]

2.  Primary:   Number of Participants With Any Severe or Grade 3/4 AEs   [ Time Frame: Up to post-treatment (PT) + 23 days ]

3.  Primary:   Number of Participants With Any Severe or Grade 3/4 Treatment-related AE   [ Time Frame: Up to post-treatment (PT) + 23 days ]

4.  Primary:   Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE   [ Time Frame: Up to 10 days ]

5.  Primary:   Number of Participants Who Were Permanently Discontinued From the Study Due to an AE   [ Time Frame: Up to post-treatment (PT) + 23 days ]

6.  Primary:   Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5   [ Time Frame: Baseline (Day 1) and Day 5 ]

7.  Primary:   Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5   [ Time Frame: Baseline (Day 1) and Day 5 ]

8.  Primary:   Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities   [ Time Frame: Up to post-treatment (PT) + 23 days ]

9.  Primary:   Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities   [ Time Frame: Up to post-treatment (PT) + 23 days ]

10.  Primary:   Median Heart Rate at Baseline (Day 1) and Day 5   [ Time Frame: Baseline (Day 1) and Day 5 ]

11.  Primary:   Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5   [ Time Frame: Baseline (Day 1) and Day 5 ]

12.  Primary:   Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5   [ Time Frame: Baseline (Day 1) and Day 5 ]

13.  Primary:   Median Respiration Rate at Baseline (Day 1) and Day 5   [ Time Frame: Baseline (Day 1) and Day 5 ]

14.  Primary:   Median Body Temperature at Baseline (Day 1) and Day 5   [ Time Frame: Baseline (Day 1) and Day 5 ]

15.  Primary:   Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1)   [ Time Frame: Baseline (Day 1) ]

16.  Primary:   Median Corrected QT Interval (QTc) for Heart Rate by Fridericia’s Formula (QTcF) and Bazett’s Formula (QTcB) at Baseline (Day 1) and Day 5   [ Time Frame: Baseline (Day 1) and Day 5 ]

17.  Secondary:   Median Time to Virologic Improvement   [ Time Frame: Up to post-treatment (PT) + 23 days ]

18.  Secondary:   Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points   [ Time Frame: Baseline (Day 1); Days 2, 3, 4, 5, 7, and 10; and post-treatment +2, +5, +9, +16, +23 days ]

19.  Secondary:   Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively   [ Time Frame: Baseline and up to post-treatment (PT) + 23 days ]

20.  Secondary:   Number of Participants With Treatment-emergent (TE) Mutations   [ Time Frame: Baseline and up to post-treatment (PT) + 23 days ]

21.  Secondary:   Median Time to Resolution of Individual Vital Signs   [ Time Frame: Up to post-treatment (PT) + 23 days ]

22.  Secondary:   Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation   [ Time Frame: Up to post-treatment (PT) + 23 days ]

23.  Secondary:   Duration of Mechanical Ventilation and Supplemental Oxygen Use   [ Time Frame: Up to discharge from the hospital ]

24.  Secondary:   Median Time to Return to Pre-morbid Functional Status   [ Time Frame: Up to post-treatment (PT) + 23 days ]

25.  Secondary:   Number of Participants With the Indicated Mortality Status at Day 14 and Day 28   [ Time Frame: Day 14 and Day 28 ]

26.  Secondary:   Median Time to Clinical Response (Sustained Resolution) of All Vital Signs (Composite)   [ Time Frame: Up to post-treatment (PT) + 23 days ]

27.  Secondary:   Number of Participants With Any AE Categorized as an Influenza Complication   [ Time Frame: Up to post-treatment (PT) + 23 days ]

28.  Secondary:   Number of Participants Who Used Any Concomitant Antibiotic Medications for Complications of Influenza   [ Time Frame: Up to post-treatment (PT) + 23 days ]

29.  Secondary:   Median Duration of Hospitalization and Intensive Care Unit (ICU) Stays   [ Time Frame: Up to discharge from hospital ]

30.  Secondary:   Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion   [ Time Frame: Day 1 and Days 3, 4, or 5 ]

31.  Secondary:   Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir   [ Time Frame: Day 1 and Days 3, 4, or 5 ]

32.  Secondary:   Geometric Mean Terminal Half Life (t1/2) of Zanamivir   [ Time Frame: Day 1 and Days 3, 4, or 5 ]

33.  Secondary:   Geometric Mean Serum Clearance of Zanamivir   [ Time Frame: Day 1 and Days 3, 4, or 5 ]

34.  Secondary:   Geometric Mean Volume of Distribution (Vd) of Zanamivir   [ Time Frame: Day 1 and Days 3, 4, or 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Two participants who withdrew consent prior to receiving intravenous zanamivir have not been captured in any of the tables.


  More Information
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01014988     History of Changes
Other Study ID Numbers: 113678
Study First Received: November 16, 2009
Results First Received: February 8, 2017
Last Updated: February 8, 2017