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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 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.

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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).

Conditions Studied

Acute Pancreatitis

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

FieldValue
Enrollment Target 42 participants
Start Date 2020-09-04
Est. Completion 2029-01
Phase Phase 1

Sponsor

St. Jude Children's Research Hospital

410 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04195347

The ClinicalTrials.gov registry entry for NCT04195347 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,314-participant average among 10 other Acute Pancreatitis trials with a reported enrollment target (98% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.