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IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01096784
First Posted: March 31, 2010
Last Update Posted: June 7, 2017
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.
Information provided by (Responsible Party):
Shire
Results First Submitted: September 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Retinopathy of Prematurity (ROP)
Intervention: Drug: rhIGF-I/rhIGFBP-3

  Participant Flow
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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 in multiple centres in Italy, the Netherlands, Poland, Sweden, the United Kingdom and the United States between 18 Jun 2010 and 30 March 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 121 participants were enrolled and randomized into the study.

Reporting Groups
  Description
rhIGF-1/rhIGFBP-3 Participants received insulin-like growth factor (rhIGF-I)/insulin-like growth factor binding protein-3 (rhIGFBP-3) 250 microgram per kilogram (mcg/kg) for 24 hours through continuous intravenous (IV) infusion from Day 0 up to 29 weeks 6 days of post-menstrual age (PMA).
Standard of Care (Control) Participants in this control group do not received any treatment other than the standard care.

Participant Flow:   Overall Study
    rhIGF-1/rhIGFBP-3   Standard of Care (Control)
STARTED   61   60 
COMPLETED   46   46 
NOT COMPLETED   15   14 
Withdrawal by Subject                2                1 
Adverse Event                11                9 
Protocol Deviation                2                2 
Administrative Decision                0                1 
Other Unspecified                0                1 



  Baseline Characteristics
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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.
Intent-to-Treat (ITT) set included all enrolled participants for whom a randomization number was assigned.

Reporting Groups
  Description
rhIGF-1/rhIGFBP-3 Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
Standard of Care (Control) Participants in this control group do not received any treatment other than the standard care.
Total Total of all reporting groups

Baseline Measures
   rhIGF-1/rhIGFBP-3   Standard of Care (Control)   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   60   121 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 25.60  (1.207)   25.62  (1.397)   25.61  (1.300) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      22  36.1%      21  35.0%      43  35.5% 
Male      39  63.9%      39  65.0%      78  64.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population   [ Time Frame: End of study ]

2.  Secondary:   Time to Discharge From Neonatal Intensive Care (TDNIC)   [ Time Frame: Day 0 to 40 Weeks Post Menstrual Age (EOS) ]

3.  Secondary:   Number of Participants With Bronchopulmonary Dysplasia (BPD)   [ Time Frame: At 36 Weeks Post Menstrual Age ]

4.  Secondary:   Rate of Change in Body Weight   [ Time Frame: Day 0 to 40 Weeks Post Menstrual Age (EOS) ]

5.  Secondary:   Rate of Change in Length   [ Time Frame: Day 0 to 40 Weeks Post Menstrual Age (EOS) ]

6.  Secondary:   Rate of Change in Head Circumference   [ Time Frame: Day 0 to 40 Weeks Post Menstrual Age (EOS) ]

7.  Secondary:   Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS   [ Time Frame: 40 Weeks PMA/ (EOS) +/- 4 days ]

8.  Secondary:   Percentage of Participants With Intraventricular Hemorrhage (IVH)   [ Time Frame: Day 0 to 40 Weeks Post Menstrual Age (EOS) ]

9.  Secondary:   Area Under Curve for Maximum Severity of ROP Stage (AUC for ROP)   [ Time Frame: Every 1-2 weeks starting at 31 weeks PMA/ EOS +/- 4 days ]

10.  Secondary:   Percentage of Participants With Maximum Severity of ROP Stage Greater Than or Equal to 3 at Any Time During the Study   [ Time Frame: Day 0 to 40 Weeks Post Menstrual Age (EOS) ]

11.  Secondary:   Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)   [ Time Frame: Day 0 to 40 Weeks Post Menstrual Age (EOS) ]

12.  Secondary:   Percentage of Serum IGF-1 Concentrations Falling Within Target Range After Infusion of rhIGF-1/rhIGFBP-3   [ Time Frame: Day 0 to 40 Weeks Post Menstrual Age (EOS) ]

13.  Secondary:   Serum Concentrations of IGFBP-3 After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3   [ Time Frame: Day 0 and Week 40 Post Menstrual Age ]

14.  Secondary:   Serum Concentrations of Acid Labile Sub-unit (ALS) After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3   [ Time Frame: Day 7 and Week 40 Post Menstrual Age ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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: Study Physician
Organization: Shire
e-mail: ClinicalTransparency@shire.com


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

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01096784     History of Changes
Other Study ID Numbers: ROPP-2008-01
2007-007872-40 ( EudraCT Number )
First Submitted: March 9, 2010
First Posted: March 31, 2010
Results First Submitted: September 28, 2016
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017