Short Bowel SyndromePhase 2/3GIFTNCT02865122
Safety and Efficacy Study in Infant With SBS
A Phase 2/3 study testing NTRA-9620 in people with Short Bowel Syndrome, run by Elgan Pharma Ltd. at 8 sites in United States.
Trial summary
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection Read more about this study
- Who is it for?
- Ages 2 to 52 weeks
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- NTRA-9620
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Mar 2017to 22 Mar 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 52 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment.
- Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment.
- After major surgical resection leading to SBS, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that ≤ 70% of the small bowel is available for nutrient absorption.
Who cannot join
- Subject has undergone any bowel lengthening procedure.
- Subject has a malabsorption disorder due to:
- congenital etiology (such as microvilli inclusion disease, tufting enteropathy)
- Untreated Hirchsprung's disease
- Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including EKG findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing first 12 weeks of the study.
- Subjects with hyperinsulinemia.
- Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL within 48 hours of treatment initiation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Florida
Gainesville, Florida, 32610
Connecticut Children's Hospital
Hartford, Connecticut, 06106
Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Missouri, 64108
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Three-Arm, Parallel-Group Trial to Assess the Efficacy and Safety of NTRA-9620 in Infants With Short Bowel Syndrome (SBS) Following Surgical Resection
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection
- Conditions
- Short Bowel Syndrome
- Being tested
- NTRA-9620, Placebo
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTRA-9620Drug
Oral daily dose
PlaceboDrug
Oral daily dose
| Study group | Role | What they receive |
|---|---|---|
| NTRA-9620-A | Experimental | NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day Receives: Drug: NTRA-9620 |
| NTRA-9620-B | Experimental | NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day Receives: Drug: NTRA-9620 |
| Placebo | Placebo comparator | Placebo To be dosed orally for 24 weeks, 4 times/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in %PN/IV
Percent change in %PN/IV from baseline based on caloric intake
Measured: baseline and end of treatment or 24 weeks, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start20 Mar 2017
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Why it stopped: Sponsor decision based on enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elgan Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865122
- Sponsor's protocol ID
- GIFT-02
- Acronym
- GIFT
- Status last verified
- Oct 2021
- First submitted
- 9 Aug 2016
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Three-Arm, Parallel-Group Trial to Assess the Efficacy and Safety of NTRA-9620 in Infants With Short Bowel Syndrome (SBS) Following Surgical Resection
- ClinicalTrials.gov ID
- NCT02865122
- Acronym / sponsor ID
- GIFT / GIFT-02
- Conditions
- Short Bowel Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision based on enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Elgan Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 12 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to evaluate the efficacy and safety of NTRA-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with SBS following surgical resection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NTRA-9620-A | Experimental | Drug: NTRA-9620NTRA-9620 Dose 1 To be dosed orally for 24 weeks, 4 times/day |
| NTRA-9620-B | Experimental | Drug: NTRA-9620NTRA-9620 Dose 2 To be dosed orally for 24 weeks, 4 times/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo To be dosed orally for 24 weeks, 4 times/day |
Who may qualify
- Ages
- 2 to 52 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment.
- Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment.
- After major surgical resection leading to SBS, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that ≤ 70% of the small bowel is available for nutrient absorption.
Key exclusion criteria (7 listed)
- Subject has undergone any bowel lengthening procedure.
- Subject has a malabsorption disorder due to:
- Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including EKG findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing first 12 weeks of the study.
- Subjects with hyperinsulinemia.
- Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL within 48 hours of treatment initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTRA-9620Oral daily dose | Drug | NTRA-9620-A, NTRA-9620-B |
| PlaceboOral daily dose | Drug | Placebo |
Primary outcome
Percent Change in %PN/IV
Time frame: baseline and end of treatment or 24 weeks, whichever occurs first
Percent change in %PN/IV from baseline based on caloric intake
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NTRA-9620 in people with Short Bowel Syndrome, run by Elgan Pharma Ltd. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in %PN/IV (time frame: baseline and end of treatment or 24 weeks, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.