NCT01413581|TerminatedPhase 3DMC

Study Stopped

Primary endpoint showed no stat significant difference. FU \> M12 terminated.

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

LAIF

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

Swedish Orphan Biovitrum ClinicalTrials.gov

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1 other identifier

BVT.BSSL-030

Study Type

interventional

Target

415

Locations

10 countries

Sites

Timeline

RegisteredAug 2011

StartedMay 2011

CompletionAug 2014

Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

415

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started May 2011

Typical duration for phase_3

Geographic Reach

10 countries

49 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

Study Start

First participant enrolled

May 1, 2011

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed

2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed

Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

June 8, 2011

Last Update Submit

July 29, 2015

Conditions

Prevention of Growth Restriction

Keywords

rhBSSLpreterm infantsSwedish Orphan Biovitrumgrowth velocityPrevention of growth restriction

Outcome Measures

Primary Outcomes (1)

Growth velocity in grams per kilogram per day during 4 weeks of treatment.
Baseline and Day 29

Secondary Outcomes (46)

Change from baseline in body weight (g) at 3 months
Baseline and Month 3
Body weight (g) at 12 months' corrected age
12 months´ corrected age
Body weight (g) at 24 months' corrected age
24 months´ corrected age
Change from baseline in total body length (mm) at 4 weeks
Baseline and Day 29
Change from baseline in total body length (mm) at 3 months
Baseline and Month 3
+41 more secondary outcomes

Study Arms (2)

rhBSSL

EXPERIMENTAL

rhBSSL (recombinant human bile-salt-stimulated lipase)

Drug: rhBSSL (recombinant human bile-salt-stimulated lipase)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

rhBSSL (recombinant human bile-salt-stimulated lipase)DRUG

rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

rhBSSL

PlaceboDRUG

Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.

Placebo

Eligibility Criteria

AgeUp to 10 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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 who is expected not to receive any fresh breast milk for 4 weeks following treatment initiation.
Informed consent is obtained.

You may not qualify if:

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.

Contact the study team to confirm eligibility.