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Insulin-Like Growth Factor I (IGF-I) in the Prevention of Complications of Preterm Birth

This study is currently recruiting participants.
Verified January 2013 by Premacure AB
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Lund University Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Premacure AB
ClinicalTrials.gov Identifier:
NCT01096784
First received: March 9, 2010
Last updated: January 13, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a randomized multicenter trial on pharmacokinetics, safety and efficacy with administration of Insulin-Like Growth Factor I (IGF-I) in preterm infants to prevent complications of preterm birth.


Condition Intervention Phase
Retinopathy of Prematurity
Bronchopulmonary Dysplasia
Body Weight
Body Length
Brain Volume
 Drug: mecasermin rinfabate
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Determination of the rhIGF-I/rhIGFBP-3 Dose, Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-I Levels Within Physiological Levels in Premature Infants, to Prevent Retinopathy of Prematurity.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Premacure AB:

Primary Outcome Measures:
  • Severity of retinopathy of prematurity [ Time Frame: At term age (post menstrual week 40) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of mild and severe bronchopulmonary dysplasia [ Time Frame: At term age (post menstrual week 40) ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: At birth, day 1, 2 and 3 and thereafter twice weekly up post menstrual age week 40 (appr.) ] [ Designated as safety issue: No ]
    Development of body weight in treated infants will be compared with untreated controls

  • Length [ Time Frame: Once weekly up to End of Study (at term age (post menstrual week 40)) ] [ Designated as safety issue: No ]
    Development of length in treated infants will be compared with untreated controls

  • Brain volume and head circumference [ Time Frame: Study days 1, 3, 7, 14, 21 and at PMA 6 weeks and at term age (post menstrual week 40) ] [ Designated as safety issue: No ]
    Development of brain volume and head circumference in treated infants will be compared with untreated controls

  • Number of days in neonatal intensive care [ Time Frame: At home discharge ] [ Designated as safety issue: No ]
    Total number of days in neonatal intensive care prior to home discharge for treated infants will be compared with untreated controls

  • Adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
    Hematology, clinical chemistry, physical examinations and vital signs including heart rate, blood pressure, oxygen saturation and breath frequency will be monitored from birth throughout the study.

  • IGF-I levels [ Time Frame: From day of birth up to end of study ] [ Designated as safety issue: No ]
    IGF-I levels and associated pharmacokinetic parameters during and after continuous infusion of rhIGF-I/rhIGFBP-3 will be monitored from day of birth up to study end (postmenstrual week 40)

  • Blood glucose levels [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: Yes ]
  • Long term follow up [ Time Frame: At 2.5 and 5.5 years of age ] [ Designated as safety issue: Yes ]
    All infants will be screened at 2.5 and 5.5 years of age with regard to visual development. Ocular fundus photographs for digital image analysis of the retinal vascular morphology will be taken at 2.5 and 5.5 years and at 5.5 years of age the children will have a clinical physical examination, including ultrasound of heart, kidney and spleen size, as well as a test of neuropsycologic functions (e.g. WISC) and test of pulmonary function. The pubertal development will be investigated by a pediatric endocrinologist at 10.5 years for the girls and at 12 years for the boys.


Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No IGF-I administration
Standard neonatology care without administration of IGF-I
 Drug: mecasermin rinfabate
Continuous intravenous infusion
Other Name: IGF-I

Detailed Description:

Low Insulin-Like Growth Factor I (IGF-I) levels in premature infants between gestational ages of 23 and 40 weeks is a predictor of ROP. Restoration of IGF-I to normal in uteri levels may prevent ROP by allowing normal vessel growth and survival. An increase of serum IGF-I levels to approximately reach the level for corresponding gestational age (GA) of 20-60 μg/L, thus bringing levels to within physiological range, may prevent development of ROP.

In a phase-I pharmacokinetic study, the amount of recombinant human IGF-I (rhIGF-I), administered as a single infusion over three hours, required to produce Postmenstrual Age (PMA) levels of IGF-I within the normal intrauterine range for corresponding Gestational Age (GA)in premature infants was established. An algorithm was developed to predict the appropriate individual dose to reach levels of IGF-I corresponding to intrauterine levels when administering rhIGF-I as a continuous intravenous infusion.

In the present study, the dose of rhIGF-I needed, when administered as continuous infusion, to keep the PMA levels of IGF-I within the normal intrauterine range for corresponding GA from day after birth (study day 1) and up to and including maximally PMA age 31 weeks + 6 days (which is the same anticipated approach of a future preventive treatment), will be investigated. Moreover, the outcome on ROP development and other efficacy endpoints by increasing and maintaining the IGF-I levels to within intrauterine levels will be compared to a control group randomized to receive standard neonatal care without administration of study drug

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent from parents/guardians;
  • Subject must be between 26 weeks + 0 days and 27 weeks +6 days gestation (Section A) or between 23 weeks + 0 days and 27 weeks + 6 days gestation (Section B, C and Control Groups)

Exclusion Criteria:

  • Infants born small for gestational age (SGA), i.e. weight at birth <-2 SDS (Section A only);
  • Detectable gross malformation;
  • Known or suspected chromosomal abnormality, genetic disorder, or syndrome, according to the investigator‟s opinion;
  • Persistent plasma glucose level <2.5 mmol/L or >10 mmol/L at study day 0 (day of birth);
  • Anticipated need of administration of erythropoietin (rhEPO) during treatment with study drug
  • Mother with diabetes requiring insulin;
  • Clinically significant neurological disease according to the investigator‟s opinion;
  • Any other condition or therapy that, in the investigator's opinion, may pose a risk to the subject or interfere with the subject‟s ability to be compliant with this protocol or interfere with interpretation of results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096784

Contacts
Contact: Ann Hellstrom, MD Professor +46 31 343 47 22 ann.hellstrom@medfak.gu.se

Locations
Sweden
Gothenburg University Hospital Not yet recruiting
Gothenburg, Sweden
Contact: Aimon Niklasson, MD, PhD            
Principal Investigator: Ann Hellström, MD, Professor            
Lund University Hospital Recruiting
Lund, Sweden
Contact: David Ley, MD, PhD            
Principal Investigator: David Ley, MD, Professor            
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Boubou Hallberg, MD, PhD            
Principal Investigator: Boubou Hallberg, MD, PhD            
Sponsors and Collaborators
Premacure AB
Sahlgrenska University Hospital, Sweden
Lund University Hospital
Karolinska University Hospital
Investigators
Principal Investigator: David Ley, MD, PhD Lund University Hospital, Sweden
Principal Investigator: Niklasson Aimon, MD, PhD Gothenburg University Hospital, Sweden
Principal Investigator: Boubou Hallberg, MD, PhD Karolinska University Hospital
  More Information

Additional Information:
The Sahlgrenska Center for Pediatric Ophthalmology Research  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Premacure AB
ClinicalTrials.gov Identifier: NCT01096784     History of Changes
Other Study ID Numbers: ROPP-2008-01, 2007-007872-40
Study First Received: March 9, 2010
Last Updated: January 13, 2013
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by Premacure AB:
insulin-like growth factor i
IGF-I
retinopathy of prematurity
 ROP
bronchopulmonary dysplasia
BPD

Additional relevant MeSH terms:
Body Weight
Bronchopulmonary Dysplasia
Retinal Diseases
Retinopathy of Prematurity
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Eye Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013