HealthyPhase 4INFUSE-NSLRNCT00656370
Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)
A Phase 4 study testing recombinant human hyaluronidase in people with Healthy, run by Halozyme Therapeutics at 1 site in United States.
Trial summary
Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- recombinant human hyaluronidase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to 30 Jan 2008
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18 to 60 years of age.
- Intact normal skin without in the areas intended for infusion.
- No fluid intake for 12 hours prior to the start of the study infusion.
- Vital signs (Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR)) within normal range.
- Metabolic panel within normal range.
- A negative urine or serum pregnancy test.
- Signed, written Institutional Review Board (IRB)-approved informed consent.
Who cannot join
- Lower extremity edema.
- Lower extremity pathology that could interfere with study outcome.
- Rales on lung auscultation.
- History of cardiovascular disease.
- Allergy to hyaluronidase.
- Allergy to bee or vespid venom.
- Pregnancy or breast-feeding woman.
- Use of any investigational drug or device within 30 days of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The INcreased Flow Utilizing Subcutaneously-Enabled Normal Saline and Lactated Ringer's (INFUSE-NSLR) Study: A Phase IV, Double-Blind, Randomized Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex) in Volunteer Subjects
Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units.
In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150 units of hylenex.
In Stage 2, the comparison will be NS solution and buffered NS solution.
Read the detailed description
This Phase IV, randomized, double-blinded study in volunteer subjects to evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. The study will be conducted in two sequential stages.
In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
Tolerability will be assessed based on the subject's self-assessment of discomfort on a visual analog scale (VAS). Safety will be assessed by physical examination targeted at infusion sites, vital signs, and adverse events. The amount of fluid infused will be assessed by weighing the infusion bag, fluid and tubing at designated time points, and allowing the determination of flow rate.
Stage 2 will be conducted only if the observed Stage 1 VAS mean maximum pain score is at least 25 mm higher for one solution compared to the other. Stage 2 will evaluate the tolerability, safety, and flow rates of subcutaneously infused NS solution and buffered NS solution.
- Conditions
- Healthy
- Being tested
- recombinant human hyaluronidase
- Keywords
- Hylenex, subcutaneous infusion, hyaluronidase, rHuPH20, recombinant human hyaluronidase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human hyaluronidaseDrug
Also called Hylenex
150 Units in 1mL
| Study group | Role | What they receive |
|---|---|---|
| NS Infusion Group | Experimental | Normal Saline (NS) and Hylenex Receives: Drug: recombinant human hyaluronidase |
| LR Infusion Group | Experimental | Lactated Ringer's (LR) and Hylenex Receives: Drug: recombinant human hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)
Participant's self-assessment of discomfort at the infusion site by means of a validated VAS with a range of 0 millimeters (mm) (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of normal saline (NS) versus Lactated Ringer's (LR), each following an SC slow-push injection of 150 Units (U) Hylenex.
Measured: Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes on Day 1
Secondary outcomes (5)
Number of Participants Assessed for Safety Measures
Safety outcome measures included adverse events (AEs), physical examinations (targeted physical examination included lung auscultation for rales, checking for edema, evaluation of infusion sites, positives on a review of systems, and follow-up of findings from previous physical examinations), and vital signs (systolic blood pressure, diastolic blood pressure, heart rate, and respiration rate).
Measured: Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left (up to approximately 8 days)
Average Infusion Flow Rate (Milliliters Per Hour [mL/hr]) Derived From the Time to Infuse up to 500 mL of Solution
The infusion flow rate (mL/h) was derived from the time to subcutaneously (SC) infuse up to 500 mL of NS or LR solution (following SC injection of 150 Units hylenex) by measuring the change in weight of the infusion bag, fluid, and tubing.
Measured: During infusion on Day 1
Percent Change From Baseline Thigh Circumference to Maximum Post-Baseline Thigh Circumference at Infusion Sites
Thigh circumference was measured in centimeters at 7 time points before, during, and after subcutaneous infusion of 500 mL NS or LR solution.
Measured: Before the infusion, during the infusion, after the infusion, and discharge (Day 1)
Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference
Thigh circumference was measured at the level of the angiocatheter with a flexible measuring tape prior to infusion initiation (Baseline), at the midpoint for each infusion, and at the end of each infusion.
Measured: Before the infusion (Baseline) until discharge (Day 1)
Number of Participant's With the Indicated Global Preference for Infusion (Left Versus Right Thigh)
Participants blinded to the type of infusion were asked to state their preference for the left or right infusion following all infusion day (Day 1) activities and assessments. The preference for the left or right infusion indicated which infusion was preferred: NS or LR.
Measured: End of infusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startDec 2007
- Primary completion30 Jan 2008
- Study completion30 Jan 2008
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 HealthyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halozyme Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Shanthini Daniel, M.D., Principal investigator, Jasper Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656370
- Sponsor's protocol ID
- HZ2-07-03
- Acronym
- INFUSE-NSLR
- Status last verified
- Sep 2018
- First submitted
- 3 Apr 2008
- Last updated
- 17 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INcreased Flow Utilizing Subcutaneously-Enabled Normal Saline and Lactated Ringer's (INFUSE-NSLR) Study: A Phase IV, Double-Blind, Randomized Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex) in Volunteer Subjects
- ClinicalTrials.gov ID
- NCT00656370
- Acronym / sponsor ID
- INFUSE-NSLR / HZ2-07-03
- Conditions
- Healthy
- Keywords
- Hylenex, subcutaneous infusion, hyaluronidase, rHuPH20, recombinant human hyaluronidase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2007
- Primary completion
- 30 Jan 2008 (actual)
- Study completion
- 30 Jan 2008 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Posted 14 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units.
In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150 units of hylenex.
In Stage 2, the comparison will be NS solution and buffered NS solution.
Detailed description
This Phase IV, randomized, double-blinded study in volunteer subjects to evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. The study will be conducted in two sequential stages.
In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
Tolerability will be assessed based on the subject's self-assessment of discomfort on a visual analog scale (VAS). Safety will be assessed by physical examination targeted at infusion sites, vital signs, and adverse events. The amount of fluid infused will be assessed by weighing the infusion bag, fluid and tubing at designated time points, and allowing the determination of flow rate.
Stage 2 will be conducted only if the observed Stage 1 VAS mean maximum pain score is at least 25 mm higher for one solution compared to the other. Stage 2 will evaluate the tolerability, safety, and flow rates of subcutaneously infused NS solution and buffered NS solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NS Infusion Group | Experimental | Drug: recombinant human hyaluronidaseNormal Saline (NS) and Hylenex |
| LR Infusion Group | Experimental | Drug: recombinant human hyaluronidaseLactated Ringer's (LR) and Hylenex |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female, 18 to 60 years of age.
- Intact normal skin without in the areas intended for infusion.
- No fluid intake for 12 hours prior to the start of the study infusion.
- Vital signs (Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR)) within normal range.
- Metabolic panel within normal range.
Key exclusion criteria (8 listed)
- Lower extremity edema.
- Lower extremity pathology that could interfere with study outcome.
- Rales on lung auscultation.
- History of cardiovascular disease.
- Allergy to hyaluronidase.
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 |
|---|---|---|
| recombinant human hyaluronidaseAlso: Hylenex150 Units in 1mL | Drug | LR Infusion Group, NS Infusion Group |
Primary outcome
The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)
Time frame: Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes on Day 1
Participant's self-assessment of discomfort at the infusion site by means of a validated VAS with a range of 0 millimeters (mm) (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of normal saline (NS) versus Lactated Ringer's (LR), each following an SC slow-push injection of 150 Units (U) Hylenex.
5 secondary outcomes
Number of Participants Assessed for Safety Measures
Time frame: Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left (up to approximately 8 days)
Average Infusion Flow Rate (Milliliters Per Hour [mL/hr]) Derived From the Time to Infuse up to 500 mL of Solution
Time frame: During infusion on Day 1
Percent Change From Baseline Thigh Circumference to Maximum Post-Baseline Thigh Circumference at Infusion Sites
Time frame: Before the infusion, during the infusion, after the infusion, and discharge (Day 1)
Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference
Time frame: Before the infusion (Baseline) until discharge (Day 1)
Number of Participant's With the Indicated Global Preference for Infusion (Left Versus Right Thigh)
Time frame: End of infusion (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shanthini Daniel, M.D. principal investigator
Jasper Clinic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant human hyaluronidase in people with Healthy, run by Halozyme Therapeutics at 1 site 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 7 inclusion and 8 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 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 14 May 2010). 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?
The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS) (time frame: Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes on Day 1). 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 17 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.