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Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants (LAIF)

This study is currently recruiting participants.
Verified April 2013 by Swedish Orphan Biovitrum
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT01413581
First received: June 8, 2011
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.


Condition Intervention Phase
Prevention of Growth Restriction
 Drug: rhBSSL (recombinant human bile-salt-stimulated lipase)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:
  • Growth velocity in grams per kilogram per day during 4 weeks of treatment. [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in body weight (g) at 3 months [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Body weight at 12 and 24 months' corrected age [ Time Frame: 12 and 24 months´ corrected age ] [ Designated as safety issue: No ]
  • Change from baseline in total body length (mm) at 4 weeks [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
  • Change from baseline in total body length (mm) at 3 months [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Time to readiness for discharge. [ Time Frame: Baseline to time point when readiness for discharge ] [ Designated as safety issue: No ]
  • Time to discharge. [ Time Frame: Baseline to time for discharge ] [ Designated as safety issue: No ]
  • Change from baseline in head circumference (mm) at 4 weeks. [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
  • Head circumference (mm) at 3 months. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
  • Head circumference at 12 and 24 months' corrected age. [ Time Frame: 12 and 24 months´ corrected age ] [ Designated as safety issue: No ]
  • Number and percentage of patients with treatment emergent AE, SAE and AE leading to discontinuation by system organ class and preferred term (coded by MedDRA) [ Time Frame: Baseline to Month 3 ] [ Designated as safety issue: Yes ]
  • Change from baseline in Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate at 4 weeks [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: Yes ]
  • Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate at 4 weeks [ Time Frame: Day 29 ] [ Designated as safety issue: Yes ]
  • Number and percentage of patients with a clinically significant abnormal laboratory assessment during treatment [ Time Frame: Baseline to Day 29 ] [ Designated as safety issue: Yes ]
  • Bayley Scale of Infant and Toddler Development [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Neurodevelopment Disability Composite [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Child Behavior Checklist [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 432
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhBSSL Drug: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL or placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
Placebo Comparator: Placebo Drug: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL or placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.

Detailed Description:

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo. The infants should be born before week 32 of gestational age.

The study drug, rhBSSL or placebo, will be administered during a 4 week treatment period by adding it to either infant formula or pasteurized breast milk.

The study will also evaluate the safety and tolerability of rhBSSL.

Eligible patients will be randomized in a ratio of 1:1 (rhBSSL:placebo). The study consists of maximum 1 week screening period, a 4-week treatment period and a 2 year follow-up period.

  Eligibility

Ages Eligible for Study:   up to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants born before week 32 of gestation.
  • Preterm infant who is less than 33 weeks postmenstrual age at the time of randomization.
  • Preterm infant who is appropriate for gestational age (AGA) or small for gestational age (SGA) at birth.
  • Preterm infant who is receiving food enterally (bottle or gavage tube) at a level of at least 100 ml/kg/day at randomization.
  • Preterm infant whose enteral feeding consists of only infant formula or only pasteurized breast milk at the time of inclusion, and who are expected to remain on only infant formula for 4 weeks, or only pasteurized breast milk for at least 2 weeks following treatment initiation.
  • Preterm infant who is expected not to receive any fresh breast milk for 4 weeks following treatment initiation.
  • Informed consent is obtained.

Exclusion Criteria:

  • Expected stay in the hospital is less than 4 weeks from the first dose of study drug.
  • Criteria to ensure no disease or treatment affecting growth or development, e.g. brain disease, necrotizing enterocolitis.
  • Enrolled in another concurrent clinical intervention study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413581

Contacts
Contact: Anna Olsson, MSc Pharm +46 8 697 2000 anna.olsson@sobi.com
Contact: Maria Öhman, MSc Pharm +46 8 697 2000 maria.ohman@sobi.com

  Show 66 Study Locations
Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
Study Director: Kristina Timdahl, MD Swedish Orphan Biovitrum
  More Information

No publications provided

Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT01413581     History of Changes
Other Study ID Numbers: BVT.BSSL-030
Study First Received: June 8, 2011
Last Updated: April 11, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Swedish Orphan Biovitrum:
rhBSSL
preterm infants
Swedish Orphan Biovitrum
growth velocity
Prevention of growth restriction

ClinicalTrials.gov processed this record on June 17, 2013