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OHB-607 for Bronchopulmonary Dysplasia

Phase 2
Waitlist Available
Research Sponsored by Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 6 months ca through 24 months ca
Awards & highlights

Study Summary

This trial will test if an experimental drug can help improve lung function in premature babies.

Who is the study for?
This trial is for extremely premature infants born between 23 and 27 weeks of gestation. Parents must consent to the study, which excludes infants with significant neurological disease, major congenital malformations, genetic disorders, or those whose mothers had severe COVID-19 during pregnancy.Check my eligibility
What is being tested?
The study tests OHB-607's effectiveness in preventing chronic lung disease in extremely premature babies compared to standard care alone. It aims to see if this drug can reduce long-term respiratory issues these infants often face.See study design
What are the potential side effects?
Potential side effects are not specified here but would typically include reactions expected from introducing a new medication into an infant's system such as digestive disturbances or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 months ca through 24 months ca
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 6 months ca through 24 months ca for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death, whichever comes first as compared to the SNC group
Secondary outcome measures
Exposure-response Pharmacokinetics/Pharmacodynamics relationships
Incidence and severity of BPD
Incidence and severity of IVH
+4 more

Side effects data

From 2008 Phase 3 trial • 137 Patients • NCT00125164
24%
Upper respiratory tract infection
16%
Headache
16%
Cough
12%
Otitis media
12%
Sinusitis
8%
Ear pain
8%
Pharyngitis streptococcal
8%
Nasopharyngitis
4%
Pain in extremity
4%
Cellulitis
4%
Hypoglycemia
4%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Untreated
40 μg/kg BID (Twice Daily Dosing)
80 μg/kg BID (Twice Daily Dosing)
120 μg/kg BID (Twice Daily Dosing)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OHB-607Experimental Treatment1 Intervention
Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
Group II: Standard Neonatal CareActive Control1 Intervention
Standard neonatal care alone will be provided.

Find a Location

Who is running the clinical trial?

ShireLead Sponsor
456 Previous Clinical Trials
96,954 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
26 Patients Enrolled for Bronchopulmonary Dysplasia
OHB Neonatology Ltd.Lead Sponsor
Oak Hill Bio LtdLead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
26 Patients Enrolled for Bronchopulmonary Dysplasia

Media Library

OHB-607 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03253263 — Phase 2
Bronchopulmonary Dysplasia Research Study Groups: OHB-607, Standard Neonatal Care
Bronchopulmonary Dysplasia Clinical Trial 2023: OHB-607 Highlights & Side Effects. Trial Name: NCT03253263 — Phase 2
OHB-607 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03253263 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

What conditions are most commonly treated with SHP607?

"The drug SHP607 has been demonstrated to provide relief from antibodies, blocking, growth failure and abetalipoproteinemia."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~109 spots leftby Aug 2026