Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02265575
• Date of registration: 07/10/2014
• Prospective Registration: No
• Primary sponsor: Massachusetts General Hospital
• Public title: Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration HARK
• Scientific title: Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration
• Date of first enrolment: October 2014
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02265575
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Kenya

Contacts

• Name: Brett D. Nelson, MD,MPH,DTM&H
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients presenting to a participating facility with moderate-to-severe
dehydration will be considered for participation. Other inclusion criteria will
include:

- Patients over the age of 1 month

- Patients presenting with moderate-to-severe dehydration who failed to improve or are
not candidates for oral rehydration therapy and IV access is not successful twice

- Parents or legal guardian(s) available to provide written informed consent

Exclusion Criteria:

- There will be no limitation based on race, tribe, language, or sexual orientation in
the study for any patients who meet treatment criteria. There are no exclusions based
on language. Exclusion criteria will include:

- Any condition precluding SC infusion or infusion-site evaluation in all possible
anatomic locations, including the upper back, anterior thighs, abdomen, and other
potential areas for hSC therapy

- Any reason (before study enrollment) for a hospital admission or extended stay for
other than dehydration-related illness

- Known hypersensitivity to hyaluronidase or any ingredient in the study formulation of
recombinant human hyaluronidase

- Any patient not eligible for IV or SC fluids as determined by the local clinician

- Any medical condition likely to interfere with the patient's ability to fully complete
all protocol-specified interventions, the ability to undergo all protocol-specified
assessments, or likely to prolong the patient's need for medical attention beyond that
required for addressing the dehydration-related illness



Age minimum: 1 Month
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dehydration

Intervention(s)

Drug: Hyaluronic Acid

Primary Outcome(s)

Time to recovery [Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days]

Secondary Outcome(s)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days]

Secondary ID(s)

2014P001390

Source(s) of Monetary Support

Please refer to primary and secondary sponsors