Single arm study for Chronic Granulomatous Disease

National Institutes of Health Clinical Center, Bethesda, MD
Chronic Granulomatous DiseaseJSP191 - Biological
Eligibility
4 - 65
All Sexes

Study Summary

This trial tests if a study drug (JSP191) can improve success of stem cell transplants for people 4-65 w/ Chronic Granulomatous Disease.

Eligible Conditions
  • Chronic Granulomatous Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Day 100 and 2 years post transplant

Year 2
Early and long term engraftment
Week 104
Safety
Week 104
Incidence of graft-vs-host disease (GvHD)
Incidence of viral reactivation

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
4D-110
1
Empagliflozin
1
gp91 Grans

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Single arm study
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Single arm study · No Placebo Group · Phase < 1

Single arm study
Biological
Experimental Group · 1 Intervention: JSP191 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 100 and 2 years post transplant

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,186 Previous Clinical Trials
4,982,079 Total Patients Enrolled
Elizabeth M Kang, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
10 Previous Clinical Trials
354 Total Patients Enrolled

Eligibility Criteria

Age 4 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between the ages of 4 and 65.
You must be using an FDA-approved contraceptive method such as pills, patch, Norplant, or Depo-Provera.
You need to use a condom with sperm-killing gel during the trial if you are a male participant.
You have been diagnosed with CGD (Chronic Granulomatous Disease).
Your underlying disease is severe and requires a transplant or you have very low levels of oxidase production.
You have a donor who is a match for your transplant, but they are not a family member.
You must be able to stay within one hour of the NIH for the first three months after your transplant. You also need to have a family member or someone else to stay with you during this time.
You need to appoint a trusted person to make healthcare decisions for you if you are unable to do so.
The male partner has had a procedure to prevent them from being able to have children.
References

Frequently Asked Questions

Is there still capacity in this research project for new participants?

"Unfortunately, this clinical trial is no longer in the process of recruiting patients. Initially posted on December 6th 2022 and last updated November 30th 2022, it has since ceased to look for new participants; however, there are 21 other trials that remain receptive to new enrollees." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor accepting volunteers who are 50 years or older?

"The eligibility criteria for this medical experiment necessitates that participants are between 4 and 65 years of age. Simultaneously, there are 15 studies open to minors and 13 trials accessible for individuals over the age of 65." - Anonymous Online Contributor

Unverified Answer

Is it possible for me to join this research endeavor?

"This clinical trial is seeking to enrol 30 individuals aged 4-65 years who are diagnosed with Chronic Granulomatous Disease (CGD). To be admitted, participants must meet the following conditions: demonstrate CGD symptoms and complications; have an unrelated donor ready for transplantation or a Quartile 1/2 oxidase production level; reside within one hour of NIH upon post-transplant period commencement; appoint a responsible adult relative as Durable Power of Attorney for Health Care Decision Making through form NIH 200. Additionally, female patients require contraceptive methods such as oral pills, patches, Norplant implants, Depo-Provera injections etc" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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