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Monoclonal Antibodies

Dose escalation for Thrombocytopenic Purpura

Phase 1

Recruiting

Research Sponsored by Hutchmed

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 - week 24

Awards & highlights

Study Summary

"This trial will test the safety, side effects, and effectiveness of HMPL-523 in adults with ITP at multiple locations with full transparency about the treatment being administered."

Who is the study for?

Adults with immune thrombocytopenia (ITP), a condition where the blood doesn't clot well due to low platelet count, can join this trial. Specific details on who can or cannot participate are not provided here.Check my eligibility

What is being tested?

The study is testing HMPL-523's safety and how well it works in adults with ITP. It's an open-label, multicenter trial, meaning both researchers and participants know what treatment is being given.See study design

What are the potential side effects?

Potential side effects of HMPL-523 aren't listed here but typically include reactions at the site of administration, bleeding issues due to low platelets, and possibly other immune-related effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 - week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 - week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 - week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicities

Safety and tolerability of HMPL-523 in adult subjects with primary ITP

Secondary outcome measures

AUCtau (area under the concentration-time curve over a dosage interval)

Cmax (maximum plasma drug concentration)

Cmin (minimum plasma drug concentration)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose optimization stageExperimental Treatment1 Intervention

In part 2 subjects will be randomized in a 1:1 ratio between the 2 dose levels selected at the end of part 1.

Group II: Dose escalationExperimental Treatment1 Intervention

Part 1 will consist of the following 3 dose levels: 300, 400, and 500 mg once daily (QD).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HMPL-523

2022

Completed Phase 1

~220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

HutchmedLead Sponsor

29 Previous Clinical Trials

5,712 Total Patients Enrolled

Vijay Jayaprakash, MD, PhDStudy DirectorHutchmed

William Schelman, MD, PhDStudy DirectorHutchmed

2 Previous Clinical Trials

803 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At present, how many locations are hosting this particular clinical trial?

"Patients can enroll in this trial at multiple esteemed institutions including The Perth Blood Institute (PBI) Hollywood Specialist Centre in West Perth, Massachusetts General Hospital in Boston, Victoria, and University de Burgos in Burgos. Additionally, there are 15 other locations available for enrollment."

Answered by AI

Is the enrollment for this investigation currently open?

"According to information on clinicaltrials.gov, recruitment for this trial is presently closed. Initial posting was on March 1st, 2024, with the last update made on February 29th, 2024. Despite this study not seeking participants currently, there are a total of 689 other trials actively enrolling patients at this moment."

Answered by AI

Has the dose optimization phase received approval from the FDA?

"Based on the classification of this trial as Phase 1, Power's assessment rates the safety level for dose optimization at 1 due to the limited data supporting both safety and efficacy."

Answered by AI

What are the main goals being pursued in this clinical research?

"The main focus of this research, to be evaluated between week 1 and week 24, is the assessment of Dose Limiting Toxicities. Additional measurements will include AUCtau (area under the concentration-time curve throughout a dosing period) through blood samples analyzed for HMPL-523 and metabolite M1 levels at various intervals, Tmax (time taken to reach peak plasma drug level) as determined by analyzing blood samples measuring maximum plasma concentrations of HMPL-523 and metabolite M1, along with Cmin (lowest plasma drug concentration), assessed via blood sample analysis to determine minimal plasma concentrations of both HMPL-523 and"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)

2024. "The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06291415.

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