Clinical TrialID 5441
A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome
NCT02697240
Sickle Cell Disease
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5441
- Evidence Id
- 5441
- Core Evidence Id
- 5441
- Source Clinical Trial Id
- 5427
- Herb2 Clinical Trial Id
- HBCT005427
- Nct Id
- NCT02697240
- Title
- A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Sickle Cell Disease
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Intravenous citrulline
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult
- Enrollment
- 4
- Outcome Measure
- Number of Participants With Adverse Events, The number and severity of adverse event will be determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), 30 days|Plasma Citrulline Level, Plasma citrulline levels will be evaluated at the following time points: trough level, 10 minutes (peak level), 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours, to evaluate the pharmacokinetic profile
- Sponsor Collaborator
- University of Mississippi Medical Center
- Funded By
- OTHER
- Location
- University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States
- Other Id
- 2014-0230
- Start Date
- 2016-02
- Primary Completion Date
- 2017-04
- Completion Date
- 2017-04
- First Posted
- 2016-03-03
- Results First Posted
- 2019-04-17
- Last Update Posted
- 2019-06-25
- Study Document
- Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/40/NCT02697240/Prot_SAP_000.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT02697240
- Title Cn
- Title En
- A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome
- Bilingual Status
- semi_complete