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New treatment option for Chronic Granulomatous Disease X-linked (X-CGD)
Official title Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
ClinicalTrials.gov ID: NCT03055247
What this study is testing
What is Ibuprofen?
Ibuprofen is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic granulomatous disease x-linked (x-cgd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II exploratory study conducted to evaluate the safety and efficacy of the combination of Ibuprofen, G-CSF and Plerixafor as stem cell mobilization regimen in patients affected by X-CGD.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, men only
You may be able to join if
- Genetic diagnosis of X-CGD
- 18-45 years of age
- Karnofsky Index \> 80 %
- Adequate cardiac, renal, hepatic and pulmonary function.
- Negative thrombophilic screen and negative history for previous thrombotic events
You likely can't join if
- Previous Bone Marrow Transplantation or previous Gene Therapy.
- Use of other investigational agents within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents).
- Ongoing IFN-γ treatment (within 4 weeks).
- Symptomatic inflammatory bowel disease.
- Symptomatic viral, bacterial, or fungal infection within 6 weeks of eligibility
- Neoplasia (except local skin cancer) or history of "familial" cancer
See the full eligibility criteria
- Genetic diagnosis of X-CGD
- 18-45 years of age
- Karnofsky Index \> 80 %
- Adequate cardiac, renal, hepatic and pulmonary function.
- Negative thrombophilic screen and negative history for previous thrombotic events
- Written informed consent
- Previous Bone Marrow Transplantation or previous Gene Therapy.
- Use of other investigational agents within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents).
- Ongoing IFN-γ treatment (within 4 weeks).
- Symptomatic inflammatory bowel disease.
- Symptomatic viral, bacterial, or fungal infection within 6 weeks of eligibility
- Neoplasia (except local skin cancer) or history of "familial" cancer
- Myelodysplasia or other serious hematological disorder
- History of uncontrolled seizures and deep venous thrombosis
- Other systemic disease judged as incompatible with the procedure
- Positivity for HIV and/or HCV RNA and/or HbsAg and/or HBV DNA
- Active alcohol or substance abuse within 6 months of the study.
- Contraindications to IBU, G-CSF, Plerixafor or Pantoprazole administration
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Lazio, Italy
- Milan, Lombardy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Lazio, Italy; Milan, Lombardy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.