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Trial details
Open-label, Multicenter, Single Arm, Phase II Study Assessing Treatment Patient Preference for New Deferasirox Formulation (Film-coated Tablet) Compared to the Reference Deferasirox Dispersible Tablet Formulation
Current status:
Approved
|
Date registered:
08/07/2019
Trial version(s)
History: 06/02/2019
History: 06/02/2019
History: 06/02/2019
History: 06/02/2019
History: 06/02/2019
Current: 06/02/2019
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Main Information
Primary registry identifying number
LBCTR2019020189
Protocol number
CICL670FIC05
MOH registration number
29858/2018
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LCTR was already initiated, original file was previously submitted by paper
Date of registration in national regulatory agency
13/07/2018
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Open-label, Multicenter, Single Arm, Phase II Study Assessing Treatment Patient Preference for New Deferasirox Formulation (Film-coated Tablet) Compared to the Reference Deferasirox Dispersible Tablet Formulation
Acronym
JUPITER
Scientific title
Open-label, Multicenter, Single Arm, Phase II Study Assessing Treatment Patient Preference for New Deferasirox Formulation (Film-coated Tablet) Compared to the Reference Deferasirox Dispersible Tablet Formulation
Acronym
Brief summary of the study: English
Study to evaluate patient preference of deferasirox FCT or deferasirox DT in patient with transfusion - dependent thalassemia or non-transfusion -dependent thalassemia as measured by preference questionnaire at Week 48
Brief summary of the study: Arabic
دراسة مفتوحة اللصاقة، متعددة المراكز، وحيدة المجموعة، في المرحلة الثانية لتقييم الأفضليّة العلاجيّة للمريض لصيغة ديفيرازيروكس الجديدة (قرص مغلّف بطبقة رقيقة) مقارنة بصيغة ديفيرازيروكس المرجعيّة من قرص قابل للتفتت
Health conditions/problem studied: Specify
•Transfusion-dependent Thalassemia •Non-transfusion-dependent Thalassemia
Interventions: Specify
Deferasirox (Tablet & Dispersible)
Key inclusion and exclusion criteria: Inclusion criteria
1. Prior to any screening procedures are performed, written informed consent/assent must be provided. 2. Male and female patient aged ≥ 2 years 3. Exjade naïve patient or chelated naive patient or treated by other chelators for at least 6 months, such as: a. Deferiprone/ DFP b. Deferoxamine /DFO c. Combination (DFO + DFP) 4. Subject is willing to discontinue current iron chelation therapy at least 7 days prior to the first day and for the duration of the study 5. Patients with transfusion-dependent thalassemia (independent of underlying condition) with transfusional iron overload as shown by: -a serum ferritin level of > 1000 ng/ml at screening and if available, LIC > 3 mg Fe/g dw until 6 months prior to screening 6. Patients with non-transfusion-dependent thalassemia with iron overload as shown by: -a serum ferritin level of ≥ 800 ng/ml at screening and if available, LIC ≥ 5 mg Fe/g dw until 6 months prior to screening
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
2
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
1. Male and female patient aged < 2 years 2. Written consent/assent from patients/parents/legal representative is not obtained 3. Creatinine clearance below the contraindication limit in the locally approved prescribing information. 4. Serum creatinine level > 1.5 x ULN (upper limit of normal) 5. AST (SGOT) /ALT (SGPT) > 5 x ULN, unless if LIC confirmed as <10 mg Fe/dw within 6 months prior to screening visit. 6. Significant proteinuria as indicated by a urinary protein/creatinine ratio > 0.5 mg/mg in a non-first void urine sample. 7. Patients with significant impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 8. Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive). 9. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing any of the treatment options or patients unwilling or unable to comply with the protocol (including use of electronic devices for ePRO). 10. Patients with a known history of HIV seropositivity (Elisa or Western blot). 11. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 12. Patients participating in another clinical trial or receiving an investigational drug. 13. History of hypersensitivity to any of the study drug or excipients. 14. Significant medical condition interfering with the ability to partake in this study (e.g. systemic uncontrolled hypertension, unstable cardiac disease not controlled by standard medical therapy, systemic disease (cardiovascular, renal, hepatic, etc.). 15. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment 16. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. 17. Sexually active males unless they use a condom during intercourse while taking drug and for 28 days after stopping study medication and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
N/A: Single arm study
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
2
Study design: Purpose
Treatment
Study design: Assignment
Other
Study design: Specify assignment
Study Assessing Treatment Patient Preference for New Deferasirox Formulation (Film-coated Tablet) Compared to the Reference Deferasirox Dispersible Tablet Formulation
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
Albania, Argentina, Canada, United states, United Arab Emirates, Ukraine, Turkey, Switzerland, Saudi Arabia, Oman, Mexico , Malasia
Name of IMP
Deferasirox (ICL670)
Year of authorization
2017
Month of authorization
10
Type of IMP
Others
Type of IMP: Specify
Iron chelator
Pharmaceutical class
Non-chiral, Tridentate ligand iron chelator
Therapeutic indication
Male or female with transfusion-dependent thalassemia or non-transfusion-dependent thalassemia requiring chelation therapy due to iron overload will be included in this study.
Therapeutic benefit
Symptomatic treatment of Thalassemia
Biospecimen retention
None retained
Biospecimen description
Local lab samples are done at local lab, no samples are retained or shipped outside Lebanon.
Target sample size
10
Actual enrollment target size
5
Date of first enrollment: Type
Actual
Date of first enrollment: Date
18/10/2018
Date of study closure: Type
Actual
Date of study closure: Date
17/03/2020
Recruitment status
Complete
Date of completion
28/02/2019
IPD sharing statement plan
Yes
IPD sharing statement description
There is a plan to share IPD , however not mentioned yet on clinical trials.gov
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT02993224?id=CICL670FIC05&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
National Institute of Health (clinicaltrials.gov)
NCT02993224
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Ali
Taher
Baabda
Lebanon
009613755669
ataher@aub.edu.lb
Chronic Care Center
Scientific
Hind
Khairallah
Beirut
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Chronic Care Center
Dr Ali Taher
Hematology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Chronic Care Center
15/05/2018
Michele Abi saad
cccmas@chroniccare.org.lb
+961 3 664 310
American University of Beirut Medical Center
07/11/2017
Fuad Ziyadeh
fz05@aub.edu.lb
+9611350000#5445
Countries of Recruitment
Name
Egypt
Lebanon
Saudi Arabia
Thailand
Turkey
Viet Nam
Algeria
Morocco
Health Conditions or Problems Studied
Condition
Code
Keyword
Thalassemia
Thalassaemia, unspecified (D56.9)
Thalassemia
Interventions
Intervention
Description
Keyword
Audiometry, ECG, Chest X ray, Lab test
Audiometry, ECG, Chest X ray, Lab test
ICF, Lab, Audiometry, IMP administration
Primary Outcomes
Name
Time points
Measure
Percentage of patient preference for deferasirox FCT vs deferasirox DT
Week 48
week 48
Key Secondary Outcomes
Name
Time points
Measure
Percentage of patient preference for deferasirox FCT vs deferasirox DT vs previous previous iron chelation
Week 28
Week 28
Percentage of patient preference for deferasirox DT vs previous iron chelation
Week 4 and week 24
Week 4 and week 24
Percentage of reasons for preference of deferasirox FCT vs. deferasirox DT
Week 28 and week 48
Week 28 and week 48
Pill counts to assess drug compliance for deferasirox DT vs FCT
Baseline to wk 24, wk 25 to wk 48
Baseline to wk 24, wk 25 to wk 48
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial