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Trial details
Trial details
THETIS- Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia
Current status:
Approved
|
Date registered:
07/01/2020
Trial version(s)
Current: 01/01/2020
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2020011375
Protocol number
CICL670E2419
MOH registration number
9932/ص
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
Study was submitted previously before implementation of LBCTR
Date of registration in national regulatory agency
03/11/2014
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
THETIS- Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia
Acronym
Scientific title
An Open Label, Multi-center, Efficacy and Safety Study of Deferasirox in Iron Overloaded Patients With Non-transfusion Dependent Thalassemia
Acronym
Brief summary of the study: English
Assessed the efficacy of deferasirox in patients with non-transfusion dependent thalassemia based on change in liver iron concentration from baseline after 52 weeks of treatment. Provided further assessment of the long-term efficacy and safety of deferasirox in NTDT patients with iron overload (LIC ≥ 5 mg Fe/g liver dw and SF ≥ 300 ng/mL) for up to 260 weeks.
Brief summary of the study: Arabic
دراسة مفتوحة اللصاقة متعدّدة المراكز حول فعالية وسلامة دواء ديفيرازيروكس لدى مرضى التالاسيميا غير المعتمدين على نقل الدم الذين يعانون من زيادة تركيز الحديد (THETIS)
Health conditions/problem studied: Specify
Non-transfusion Dependent Thalassemia
Interventions: Specify
Drug: deferasirox Deferasirox dispersible tablets at strengths of 125 mg, 250 mg, and 500 mg were administered by oral daily dosing. Other Name: ICL670
Key inclusion and exclusion criteria: Inclusion criteria
Non-transfusion dependent congenital or chronic anemia inclusive of beta-thalassemia intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease)/ Liver iron concentration >/= 5 mg Fe/g dw Serum Ferritin >/= 300 ng/mL
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
10
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
HbS-beta Thalassemia, anticipated regular transfusion program during the study, blood transfusion 6 months prior to study start, significant proteinuria..
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
N/A
Study phase
4
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
China, Greece, Italy, Lebanon, Thailand, Tunisia, Turkey, United Kingdom
Name of IMP
Deferasirox (ICL670)
Year of authorization
2006
Month of authorization
4
Type of IMP
Others
Type of IMP: Specify
Iron chelator
Pharmaceutical class
Iron chelator
Therapeutic indication
Thalassemia
Therapeutic benefit
Change in liver iron concentration
Biospecimen retention
Samples without DNA
Biospecimen description
Samples are sent to central lab for analysis
Target sample size
20
Actual enrollment target size
20
Date of first enrollment: Type
Actual
Date of first enrollment: Date
26/02/2013
Date of study closure: Type
Actual
Date of study closure: Date
17/01/2019
Recruitment status
Complete
Date of completion
31/12/2013
IPD sharing statement plan
Yes
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT01709838?view=record
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinicaltrials.gov
NCT01709838
Sources of Monetary or Material Support
Name
Novartis Pharmaceuticals
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Ali
Taher
Beirut
Lebanon
01350000#7908
ataher@aub.edu.lb
Chronic Care Center
Scientific
Hind
Khairallah
Sin elfil
Lebanon
+961 1512002 #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
Ali Taher
Hematology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Chronic Care Center
17/11/2012
Michele Abi saad
cccmas@chroniccare.org.lb
+961 3 664 310
American University of Beirut Medical Center
30/11/2012
Fuad Ziyadeh
fz05@aub.edu.lb
961 (0) 1 350 000 ext:5445
Countries of Recruitment
Name
Lebanon
China
Greece
Italy
Thailand
Tunisia
Turkey
Health Conditions or Problems Studied
Condition
Code
Keyword
Non-transfusion Dependent Thalassemia
Thalassaemia, unspecified (D56.9)
Non-transfusion Dependent Thalassemia
Interventions
Intervention
Description
Keyword
ICF, Labs, drug administraion , Radiology
ICF, Labs, drug administraion , Radiology
ICF, Labs, drug administraion , Radiology
Primary Outcomes
Name
Time points
Measure
Absolute change in liver iron concentration measured by MRI
baseline, 52 weeks
baseline, 52 weeks
Key Secondary Outcomes
Name
Time points
Measure
•Percentage of Participants With Baseline LIC more than 15 Achieving LIC less than 5 mg
5 years
5 years
•Time to Achieving LIC less than 5 mg
5 years
5 years
Trial Results
Summary results in Lebanon
Study results globally
https://clinicaltrials.gov/ct2/show/results/NCT01709838?view=results Reference study results tab in the above link of clinical trials.gov
Date of posting of results summaries
Date of first journal publication of results
Results URL link
https://clinicaltrials.gov/ct2/show/results/NCT01709838?view=results
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
This is the final submission for this study including study results attached
02/01/2020
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