ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 295 for:    "Cytomegalic inclusion disease"

Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00466817
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : November 13, 2013
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Cytomegalovirus Infection
Interventions: Other: Placebo
Drug: Valganciclovir

  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
All 109 subjects started on valganciclovir. At the end of 6 weeks, subjects were randomized to valganciclovir or placebo. of the 109 subject that started, 12 dropped out before randomization and 1 subject was randomized but never received any blinded study drug.

Reporting Groups
  Description
Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo

Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Valganciclovir: 24 Wks of Valganciclovir

Six months of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.


Participant Flow:   Overall Study
    Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo   Valganciclovir: 24 Wks of Valganciclovir
STARTED   49   47 
COMPLETED   44   43 
NOT COMPLETED   5   4 



  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
Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo

Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period.

Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water.

Valganciclovir: 24 Wks of Valganciclovir

Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir.

Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water.

Total Total of all reporting groups

Baseline Measures
   Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo   Valganciclovir: 24 Wks of Valganciclovir   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   47   96 
Age 
[Units: Weeks]
Median (Full Range)
 19 
 (2 to 30) 
 14 
 (5 to 30) 
 15 
 (2 to 30) 
Gender 
[Units: Participants]
     
Female   20   16   36 
Male   29   31   60 
Region of Enrollment 
[Units: Participants]
     
United States   49   47   96 


  Outcome Measures

1.  Primary:   Change in Best Ear Hearing Assessments at 6 Months.   [ Time Frame: Between baseline and 6 months ]

2.  Secondary:   Adverse Events Which Lead to Permanent Discontinuation of Valganciclovir Therapy or Lead to Irreversible Outcome of the Adverse Event.   [ Time Frame: baseline through 7 months ]

3.  Secondary:   Change in Best Ear Hearing Assessments at 12 Months.   [ Time Frame: Between baseline and 12 months ]

4.  Secondary:   Change in Best Ear Hearing Assessments at 24 Months.   [ Time Frame: Between baseline and 24 months ]

5.  Secondary:   Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)   [ Time Frame: Between baseline and 6 months ]

6.  Secondary:   Number of Ears With Improvement or Protected Hearing in Hearing Assessments Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)   [ Time Frame: Between baseline and 12 months ]

7.  Secondary:   Number of Ears With Improvement or Protected Hearing Assessments Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)   [ Time Frame: Between baseline and 24 months ]

8.  Secondary:   Number of Ears With Hearing Deterioration Over Left and Right Ears at 6 Months.(Based on 84 Ears From 43 Placebo Subjects and 82 Ears From 43 Valganciclovir Subjects)   [ Time Frame: Between baseline and 6 months ]

9.  Secondary:   Number of Ears With Hearing Deterioration Over Left and Right Ears at 12 Months.(Based on 77 Ears From 40 Placebo Subjects and 79 Ears From 41 Valganciclovir Subjects)   [ Time Frame: Between baseline and 12 months ]

10.  Secondary:   Number of Ears With Hearing Deterioration Over Left and Right Ears at 24 Months.(Based on 58 Ears From 31 Placebo Subjects and 70 Ears From 37 Valganciclovir Subjects)   [ Time Frame: Between baseline and 24 months ]

11.  Secondary:   Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).   [ Time Frame: 12 Months after enrollment ]

12.  Secondary:   Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).   [ Time Frame: 12 Months after enrollment ]

13.  Secondary:   Neurological Impairment at 12 Months of Age Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).   [ Time Frame: 12 Months after enrollment ]

14.  Secondary:   Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).   [ Time Frame: 12 Months after enrollment ]

15.  Secondary:   Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).   [ Time Frame: 12 Months after enrollment ]

16.  Secondary:   Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).   [ Time Frame: 12 Months after enrollment ]

17.  Secondary:   Neurological Impairment at 12 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).   [ Time Frame: 12 Months after enrollment ]

18.  Secondary:   Neurological Impairment at 24 Months Utilizing the Bayley Scales of Infant and Toddler Development (Receptive Communication Scaled Score).   [ Time Frame: 24 Months after enrollment ]

19.  Secondary:   Neurological Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Cognitive Composite Score).   [ Time Frame: 24 months after enrollment ]

20.  Secondary:   Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Expressive Communication Scaled Score).   [ Time Frame: 24 Months after enrollment ]

21.  Secondary:   Neurologic Impairment at 24 Months of Life Utilizing the Bayley Scales of Infant and Toddler Development (Language Composite Score).   [ Time Frame: 24 Months after enrollment ]

22.  Secondary:   Neurological Impairment at 24 Months, Utilizing the Bayley Scales of Infant and Toddler Development (Fine Motor Scaled Score).   [ Time Frame: 24 Months after enrollment ]

23.  Secondary:   Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Gross Motor Scaled Score).   [ Time Frame: 24 Months after enrollment. ]

24.  Secondary:   Neurological Impairment at 24 Months of Life, Utilizing the Bayley Scales of Infant and Toddler Development (Motor Composite Score).   [ Time Frame: 24 Months after enrollment ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Kimberlin, MD
Organization: University of Alabama in Birmingham
phone: 205-934-2424
e-mail: dkimberlin@peds.uab.edu


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

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00466817     History of Changes
Other Study ID Numbers: 06-0046
CASG 112
First Submitted: April 26, 2007
First Posted: April 27, 2007
Results First Submitted: August 29, 2013
Results First Posted: November 13, 2013
Last Update Posted: August 26, 2015