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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01326845
Other study ID # CICL670A2417
Secondary ID 2011-001077-13
Status Terminated
Phase Phase 4
First received March 30, 2011
Last updated March 1, 2017
Start date December 2011
Est. completion date September 2012

Study information

Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent prior to any screening procedures

- Male or female patients = 18 years of age

- Patient must weigh between 45-135 kg

- Patients with low or intermediate (int-1) risk MDS, as determined by IPSS score or RA, RARS by WHO criteria. IPSS must be confirmed by a bone marrow examination within 6 months prior to study entry and must be hematologically stable

Deferasirox naïve:

Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation

Exclusion Criteria:

- History or current GI disease

- Systemic diseases which could prevent study treatments

- Left ventricular ejection fraction< 50 % by echo cardiography

- Serum creatinine > 1.2 x ULN at screening

- Platelet counts < 25x 109/L except in cases where guidance is already given in the local deferasirox label

- AST or ALT > 2.5 xULN at screening

Other protocol-defined inclusion/exclusion criteria may apply

Study Design


Intervention

Drug:
Deferasirox


Locations

Country Name City State
France Novartis Investigative Site Brest
France Novartis Investigative Site Caen Cedex
France Novartis Investigative Site Limoges cedex
France Novartis Investigative Site Pessac Cedex
France Novartis Investigative Site Vandoeuvre les Nancy
Italy Novartis Investigative Site Alessandria AL
Italy Novartis Investigative Site Roma
Italy Novartis Investigative Site Torino TO
South Africa Novartis Investigative Site Bloemfontein
Spain Novartis Investigative Site Madrid

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

France,  Italy,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section. 3 months
Secondary Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6. Study was prematurely terminated and not powered for efficacy. 6 months
Secondary Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups Study was prematurely terminated and not powered for efficacy. months 3 and 6.
Secondary Difference in Severity of Overall GI AEs Between the Two Treatment Groups Study was prematurely terminated and not powered for efficacy. months 3 and 6.
Secondary Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups Study was prematurely terminated and not powered for efficacy. months 3 and 6
Secondary Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups Study was prematurely terminated and not powered for efficacy. months 3 and 6
Secondary the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups Study was prematurely terminated and not powered for efficacy. 3 months, 6 months
Secondary Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups 3 months, 6 months
Secondary Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups Study was prematurely terminated and not powered for efficacy. 3 months, 6 months
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