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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02854761
Other study ID # CS-102
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received August 1, 2016
Last updated August 2, 2016
Start date September 2016

Study information

Verified date August 2016
Source Efranat Ltd.
Contact Myriam Golembo, PhD
Phone 972-8-9724972
Email myriam.golembo@efranat.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

This study evaluates the safety and tolerability of the investigational drug EF-022 in the treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months. Preliminary effect of the drug on the disease will be evaluated by following the number and severity of the lesions in the respiratory tract and the effect on voice changes.


Description:

The etiology of RRP is associated with local immune suppression at disease-involved sites.

EF-022, a Vitamin D-Binding protein Macrophage Activating Factor, modulates the innate arm of the immune system to alleviate immune suppression. The investigators hypothesize that EF-022 may modulate the immune response in a manner that might slow down or even prevent disease progression.

Adult subjects will be treated weekly with EF-022 for a period of 6 months by either intramuscular or subcutaneous administration.

The primary objective of the study is to evaluate the safety and tolerability of EF-022 administered to adult subjects with recurrent respiratory papillomatosis either IM or SC.

The main response assessment will be performed over the 6 months period by:

- Evaluating lesion size and/or number of disease-involved sites by Coltera-Derkay score

- Assessment of degree of voice disorder using the VHI-10 score

- Symptomatic assessment of dyspnea/stridor


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 6
Est. completion date
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patients with documented diagnosis of recurrent respiratory papillomatosis

2. Patients with measurable disease

3. Patients presenting at least one of the following severity criteria: Derkay score = 8 , Voice handicap index (VHI) =11

4. Adult male and female subjects, age of 18 and above (=18 yrs)

5. Patients with documentation on number of debulking procedures done during past 12 months

6. Estimated expectancy time for next debulking procedure must be at least 3 months.

7. Must be at least 4 weeks (>4 weeks) since last treatment including cytotoxic therapy, biological or immunotherapy, anti-viral therapy, molecularly targeted therapy or steroid treatment.

8. Must be at least 2 weeks (>2weeks) since last NSAID treatment.

9. Must have adequately recovered (to at least Grade 1 level) from adverse effects of prior therapies.

10. Female of child bearing potential must have a negative pregnancy test and must be practicing an effective method of birth control

11. Patients or their guardians must sign an informed consent indicating that they are aware of the investigational nature of this study

Exclusion Criteria:

1. Patient on concurrent steroids or anti-inflammatory non steroid treatment.

2. Active autoimmune disease

3. Known major immunodeficiency

4. Known to be Positive for HIV, Hepatitis B surface antigen, Hepatitis C antibody

5. Have absolute neutrophil counts below 1.5X 10^9/L

6. Hemoglobin below 10.0 g/dL

7. White blood cell counts below 3.5X10^9/L.

8. Granulocytes below 1.5X10^9/L.

9. Have Platelets below 100 X 10^9/L

10. Abnormal renal function with creatinine above 1.5X the upper limit of normal (ULN)

11. Abnormal liver function tests with bilirubin above 1.5X the ULN, AST and ALT above 2.5 X ULN.

12. Patients with active cardiovascular disease under continuous treatment

13. Patients with associated malignancy currently receiving chemotherapy and/or radiation.

14. Female adult patients that are pregnant, nursing or plan to nurse during and up to 12 months of treatment period.

15. Subjects receiving another investigational drug.

16. Patients with concurrent or history of malignancy within 5 years.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Efranat Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary CTCAE v.4.03 criteria will constitute the primary safety endpoints to be monitored throughout this study 6 months Yes
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