Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02720536
Recruitment Status : Active, not recruiting
First Posted : March 28, 2016
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Extended evaluation of deferasirox film-coated tablet (FCT) formulation

Condition or disease Intervention/treatment Phase
Chronic Iron Overload Drug: Deferasirox Phase 3

Detailed Description:

Collection of additional safety and efficacy data with deferasirox film-coated tablet (FCT) in patients completing study CICL670F2201

  • Provide patients enrolled and completing 24 weeks of treatment in the core study, CICL670F2201, the possibility to have additional treatment with the deferasirox FCT.
  • Collect additional longer term data on the safety and the tolerability of the deferasirox FCT.
  • Collect efficacy data on the deferasirox FCT in reduction or maintenance of iron burden as measured by serum ferritin level.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Open-label, Multicenter, Single Arm, Phase III Study to Collect Additional Safety and Efficacy Data With Deferasirox Film-coated Tablets in Patients Completing Study CICL670F2201
Actual Study Start Date : August 16, 2016
Estimated Primary Completion Date : July 2, 2019
Estimated Study Completion Date : July 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
Drug Information available for: Deferasirox

Arm Intervention/treatment
Experimental: Deferasirox
Treatment will be administered daily for up to 24 months. For each patient the daily dose is calculated based on the patient's actual body weight.
Drug: Deferasirox
Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 24 months or 30 days from last dose. ]

Secondary Outcome Measures :
  1. Absolute and relative change of serum ferritin level overtime [ Time Frame: Baseline, up to 24 months or 7 days of last dose ]
    Decrease or maintenance according to the individual therapeutic goal.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria for subjects:

  • Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201).
  • Are deemed to be tolerating deferasirox treatment by the investigator.
  • Provided written informed consent/assent before any study-specific procedures are performed. For pediatric patients, consent will be obtained from parent(s) or legal patient's representative. Investigators will also obtain assent of patients according to local, regional or national guidelines.

Key Exclusion for subjects:

The exclusion criteria will follow those described for the core protocol CICl670F2201, which were as follows:

  • Creatinine clearance below the contraindication limit in the locally approved prescribing information.
  • Serum creatinine > 1.5 × upper limit of normal range (ULN) at Screening
  • Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) > 5 × ULN,
  • Significant proteinuria
  • Patients with significant impaired gastrointestinal function or gastrointestinal disease
  • Clinical or laboratory evidence of active Hepatitis B or Hepatitis C
  • Patients with psychiatric or addictive disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02720536

Novartis Investigative Site
Vienna, Austria, 1140
Novartis Investigative Site
Athens, GR, Greece, GR-115 27
Novartis Investigative Site
Patra - RIO, GR, Greece, 265 04
Novartis Investigative Site
Thessaloniki, GR, Greece, 546 42
Novartis Investigative Site
Catania, CT, Italy, 95125
Novartis Investigative Site
Cona, FE, Italy, 44100
Novartis Investigative Site
Genova, GE, Italy, 16128
Novartis Investigative Site
Cagliari, ITA, Italy, 09121
Novartis Investigative Site
Lecce, LE, Italy, 73100
Novartis Investigative Site
Milano, MI, Italy, 20122
Novartis Investigative Site
Palermo, PA, Italy, 90127
Novartis Investigative Site
Palermo, PA, Italy, 90146
Novartis Investigative Site
Verona, VR, Italy, 37126
Novartis Investigative Site
Napoli, Italy, 80138
Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT02720536     History of Changes
Other Study ID Numbers: CICL670AIC04
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Myelodysplastic Syndrome
Film coated tablet

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action