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NCT04195347 · ClinicalTrials.gov registry record · Phase 1
Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
A Phase 1 study of Acute Pancreatitis, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT04195347: Recruiting Phase 1 study of Acute Pancreatitis, sponsored by St. Jude Children's Research Hospital.
NCT04195347 is a Phase 1 study of Acute Pancreatitis that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 42 participants, below the 2,314-participant average among 10 other Acute Pancreatitis trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195347, a Phase 1 study of Acute Pancreatitis, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a phase I/II clinical trial assessing the tolerability and efficacy of CM4620 in children and young adults with acute pancreatitis caused by asparaginase. The tolerability of CM4620 when given to patients receiving frontline chemotherapy will be determined. The effectiveness in reducing the severity of pancreatitis will be estimated. Primary Objectives To assess the safety of CM4620 administration in children and young adults with asparaginase associated pancreatitis (AAP). To profile dose-limiting toxicities and responses of the patients treated in the dose-finding phase. To estimate the efficacy of CM4620 to prevent pseudocyst or necrotizing pancreatitis in children with AAP. Secondary Objectives To determine the effect of CM4620 on the incidence of severe pancreatitis To determine the effect of CM4620 on the incidence of Systemic Inflammatory Response Syndrome (SIRS).
Primary Outcome
Drug safety measuring the number of CTCAE grade 3-5 events
Conditions Studied
Interventions
- DRUG CM4620
Study Locations (2)
North Carolina
- Novant Health Presbyterian Hemby Children's Hospital - Charlotte
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-09-04 |
| Est. Completion | 2029-01 |
| Phase | Phase 1 |
What NCT04195347 shows while recruiting
NCT04195347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 2,314-participant average among 10 other Acute Pancreatitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Acute Pancreatitis appearing as the primary indexed condition, and to 1 intervention - of which CM4620 is the first listed.
NCT04195347 reports a single indexed study location in North Carolina, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04195347 about?
NCT04195347 is a clinical study titled "Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase". This is a phase I/II clinical trial assessing the tolerability and efficacy of CM4620 in children and young adults with acute pancreatitis caused by asparaginase. The tolerability of CM4620 when given to patients receiving frontline chemotherapy will be determined. The effectiveness in reducing the ...
What is the current status of trial NCT04195347?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2020-09-04. Estimated completion is 2029-01.
What conditions does trial NCT04195347 study?
This clinical trial studies the following conditions: Acute Pancreatitis.
What interventions are being tested in trial NCT04195347?
The interventions under investigation include: CM4620 (DRUG).
Who is sponsoring clinical trial NCT04195347?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04195347 being conducted?
This trial has 2 study locations across North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Pancreatitis
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Where NCT04195347's enrollment target sits among peer trials
42 8th of 10 higher than 3 of 10 other Acute Pancreatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pancreatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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