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Acetaminophen and Diphenhydramine Only Product for Thrombocytopenic Purpura
Phase 1
Waitlist Available
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if it's possible to enroll children with ITP who are receiving IVIG for treatment, and if they're willing to participate in a scheduled medication regimen. They will also test if patients and families are able to stick to the schedule.
Eligible Conditions
- Idiopathic Thrombocytopenic Purpura (ITP)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Eligible Patients Agreeing to Enrollment
Secondary study objectives
Percentage of Enrolled Patients who Achieve Medication Adherence
Rate of Laboratory Evaluation with Platelet Count During Emergent Medical Evaluation
Cognitive Therapy
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Scheduled post-IVIG medicationExperimental Treatment1 Intervention
Utilization of post-IVIG medication with acetaminophen and diphenhydramine on a scheduled basis of 72 hours post-infusion.
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,022 Previous Clinical Trials
6,029,400 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving intravenous immunoglobulin (IVIG) treatment for a condition other than immune thrombocytopenia (ITP).You have experienced a severe allergic reaction called anaphylaxis after receiving IVIG infusion in the past.You are unable to take pills or other oral medications.
Research Study Groups:
This trial has the following groups:- Group 1: Scheduled post-IVIG medication
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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