Congenital HyperinsulinismPhase 2NCT02604485
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
A Phase 2 study testing Cohort 1, Cohort 2 and Cohort 3 in people with Congenital Hyperinsulinism, run by XOMA (US) LLC at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Hyperinsulinism
- What is being tested?
- Cohort 1, Cohort 2 and Cohort 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2015to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of congenital hyperinsulinism
- Duration of glucose levels less than 70mg/dL, by CGM, for an average of at least 120 minutes a day across baseline Days -3, -2, and -1 with no single duration less than 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment.
- Can safely washout of background medications used to treat hyperinsulinism.
Who cannot join
- Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists that may affect glucose metabolism
- Body Mass Index ≥ 35 kg/m2
- Pregnant females, females planning to become pregnant during the course of the study, females who have delivered 3 months before screening, or breastfeeding
- Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism (HI)
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
- Conditions
- Congenital Hyperinsulinism
- Being tested
- Cohort 1, Cohort 2, Cohort 3, Cohort 4
- Keywords
- Hypoglycemia, Congenital Hyperinsulinism
- Medical subject headings
- Congenital Hyperinsulinism, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1Drug
XOMA 358 single dose level A administered by an intravenous infusion
Cohort 2Drug
XOMA 358 single dose level B administered by an intravenous infusion
Cohort 3Drug
XOMA 358 single dose level C administered by an intravenous infusion
Cohort 4Drug
XOMA 358 single dose level D administered by an intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Other | XOMA 358 dose level A, dose level B, dose level C, and dose level D. Receives: Drug: Cohort 1; Drug: Cohort 2; Drug: Cohort 3; Drug: Cohort 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Safety assessed by treatment-emergent adverse events
Measured: 42 days
Change from baseline in glucose levels as measured using a continuous glucose monitor
Safety assessed by pre- and post-treatment measurements of vital signs and laboratory test results
Measured: 42 days
Fasting and post prandial blood glucose levels
Assessment of blood glucose collected at time points specified in the protocol
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital HyperinsulinismStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan Gordon, MD, PhD, Study director, XOMA (US) LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604485
- Sponsor's protocol ID
- X358602
- Status last verified
- Feb 2017
- First submitted
- 26 Oct 2015
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism (HI)
- ClinicalTrials.gov ID
- NCT02604485
- Acronym / sponsor ID
- X358602
- Conditions
- Congenital Hyperinsulinism
- Keywords
- Hypoglycemia, Congenital Hyperinsulinism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Other | Drug: Cohort 1, Drug: Cohort 2, Drug: Cohort 3, Drug: Cohort 4XOMA 358 dose level A, dose level B, dose level C, and dose level D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of congenital hyperinsulinism
- Duration of glucose levels less than 70mg/dL, by CGM, for an average of at least 120 minutes a day across baseline Days -3, -2, and -1 with no single duration less than 60 minutes on any of the baseline Days -3, -2, or -1, unless the subject received rescue treatment.
- Can safely washout of background medications used to treat hyperinsulinism.
Key exclusion criteria (4 listed)
- Use of any agent, such as diazoxide, octreotide, chronic systemic glucocorticoids, or β agonists that may affect glucose metabolism
- Body Mass Index ≥ 35 kg/m2
- Pregnant females, females planning to become pregnant during the course of the study, females who have delivered 3 months before screening, or breastfeeding
- Male subjects who are planning a pregnancy with a female partner during the course of the study or within 4 months after administration of study drug.
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 |
|---|---|---|
| Cohort 1XOMA 358 single dose level A administered by an intravenous infusion | Drug | Cohort |
| Cohort 2XOMA 358 single dose level B administered by an intravenous infusion | Drug | Cohort |
| Cohort 3XOMA 358 single dose level C administered by an intravenous infusion | Drug | Cohort |
| Cohort 4XOMA 358 single dose level D administered by an intravenous infusion | Drug | Cohort |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 42 days
Safety assessed by treatment-emergent adverse events
Change from baseline in glucose levels as measured using a continuous glucose monitor
Time frame: 42 days
Safety assessed by pre- and post-treatment measurements of vital signs and laboratory test results
Fasting and post prandial blood glucose levels
Time frame: 42 days
Assessment of blood glucose collected at time points specified in the protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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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.
Allan Gordon, MD, PhD study director
XOMA (US) LLC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cohort 1, Cohort 2 and Cohort 3 in people with Congenital Hyperinsulinism, run by XOMA (US) LLC at 2 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent adverse events (time frame: 42 days). The study lists 3 primary outcomes in all. 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 6 Feb 2017.