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Study Summary
This trial will test if an experimental drug can help improve lung function in premature babies.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 3 trial • 137 Patients • NCT00125164Trial Design
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- I have a genetic condition identified by my doctor.My blood sugar is very low even after taking glucose.You have a serious neurological disease that was found before the study starts, and it's confirmed by a brain ultrasound and the doctor's opinion.The mother had COVID-19 when the baby was born or had a serious case of COVID-19 while pregnant.Participants must be between 23 weeks and 27 weeks of pregnancy.
- Group 1: OHB-607
- Group 2: Standard Neonatal Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do I meet the criteria to be involved in this investigation?
"This clinical trial is inviting 81 neonatal patients between 0 and 1 day old that display bronchopulmonary dysplasia as participants. To be eligible, infants must possess a gestational age ranging from 26 weeks +0 days to 27 weeks + 6 days. Upon the completion of 75 postmenstrual age (PMA) 40 week visits across 25 participants in each treatment group, an independent data monitoring board will assess safety information and may approve acceptance of entrants with a gestation period within 23-27 weeks respectively."
Has SHP607 been evaluated in any other investigations?
"SHP607 was originally explored in 2019 at the University of Illinois at Chicago. After that, two more trials were successfully conducted. Currently there is a single clinical trial underway and many are being held out of Neptune, New jersey."
Is the trial still open to new participants?
"Accessing clinicaltrials.gov, it is apparent that this trial has stopped recruiting participants for the time being; its first posting was on May 9th 2019 and its most recent update occured on April 12th 2022. However, there are close to one thousand other medical trials still seeking qualified candidates."
Is this research endeavor the inaugural of its kind?
"Since 2019, Shire has conducted extensive research on SHP607. Initially, 81 individuals participated in the study sponsored by Shire and upon successful completion of Phase 2 drug approval stage, a new trial was initiated which is still ongoing today under the same sponsor."
What conditions are most commonly treated with SHP607?
"The drug SHP607 has been demonstrated to provide relief from antibodies, blocking, growth failure and abetalipoproteinemia."
How many participants are actively engaged in this clinical investigation?
"As of this time, recruitment for the study has closed. It was initially posted on May 9th 2019 and last updated on April 12th 2022. If you are seeking other trials that may be suitable, there are currently 934 studies searching for patients with bronchopulmonary dysplasia and 1 clinical trial is recruiting participants to test SHP607 as a treatment option."
Are elderly individuals being inducted into this experiment?
"This clinical trial allows for very young participants, as the inclusion criteria states that babies aged 0 Days to 1 Day are eligible. For those under 18 or above 65 years old, there are respectively 296 and 634 different trials available."
How many health care facilities are participating in the implementation of this experiment?
"Currently, 23 medical centres are offering this clinical trial. Notable locations include Jersey Shore University Medical Centre in Neptune, Floating Hospital for Children located in Boston and Vidant Medical Centre based in Greenville."
Has SHP607 been sanctioned by the FDA?
"Our assessment of SHP607's safety is a 2, as there has been some evidence to prove its security but no clinical data demonstrating it can be efficacious."
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