Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT01952769
Eligibility Criteria:
Inclusion criteria:
1. Age: 3-21
2. Diagnosis:
a. DIPG diagnosed based on all the following: i. Symptoms starting less than 6 weeks prior to diagnosis ii. Symptoms include one or more of the following: cranial nerve deficit, cerebellar or long tract dysfunction iii. MRI reveals a lesion infiltrating\>70% of the pons
3. patient status:
1. karnofsky or lansky (for children) scale of 60 or more (see appendix I)
2. liver function:Total bilirubin ≤ 2 ULN, ALT or AST ≤ 2.5 ULN (or \< 5 in case of liver impairment)
3. neutrophils ≥ 1,ooo/mm3, platelets ≥ 100,000/mm3,Lymphocytes ≥1000
4. Serum creatinine ≤ 1.5 ULN
4. Life expectancy of at least 4 months
5. Pregnancy:
1. Negative pregnancy test in women of childbearing potential
2. Use of an effective contraceptive method during the whole treatment and up to 3 months after the completion of treatment in males and females
6. prior informed consent signed
Exclusion criteria:
1. Severe bacterial, viral or fungal infection (Grade \> 2 NCI-CTCAE v.4.0)
2. Any other serious uncontrolled medical condition (including active bleeding or non healing wound)
3. Pregnant or breastfeeding women
4. Participation in another clinical trial up to 10 days prior to study entry
5. Steroid treatment in a dose more than to 3mg dexamethasone / m2 \*
6. Past infection with HCV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT01952769
Study Brief:
Protocol Section:
NCT01952769