Chronic Iron Overload Clinical Trial
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
Verified date | February 2020 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Extend evaluation of deferasirox film-coated tablet (FCT) formulation
Status | Completed |
Enrollment | 53 |
Est. completion date | July 23, 2019 |
Est. primary completion date | July 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility |
Key Inclusion Criteria for subjects: - Completed 24-weeks of study treatment as described in the core protocol (CICL670F2201). - Were deemed to have tolerated deferasirox treatment by the investigator. - Provided written informed consent/assent before any study-specific procedures were performed. For pediatric patients, consent was obtained from parent(s) or legal patient's representative. Investigators were to have also obtained assent of patients according to local, regional or national guidelines. Key Exclusion for subjects: The exclusion criteria followed 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 - Patients with a known history of HIV seropositivity (Elisa or Western blot). - History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was an evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. - Patients with a history of hypersensitivity to any of the study drug or excipients. - Patients with significant medical condition that could interfere with the ability to participate in this study - Patients who were participating in another clinical trial or receiving an investigational drug. - Patients using prohibited medication, - Patients with liver disease with severity of Child-Pugh Class B or C. - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they were using effective methods of contraception during dosing of study treatment |
Country | Name | City | State |
---|---|---|---|
Austria | Novartis Investigative Site | Vienna | |
Greece | Novartis Investigative Site | Goudi-Athens | GR |
Greece | Novartis Investigative Site | Patras | |
Greece | Novartis Investigative Site | Thessaloniki | |
Italy | Novartis Investigative Site | Cagliari | ITA |
Italy | Novartis Investigative Site | Catania | CT |
Italy | Novartis Investigative Site | Cona | FE |
Italy | Novartis Investigative Site | Genova | GE |
Italy | Novartis Investigative Site | Lecce | LE |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Napoli | |
Italy | Novartis Investigative Site | Palermo | PA |
Italy | Novartis Investigative Site | Palermo | PA |
Italy | Novartis Investigative Site | Verona | VR |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Austria, Greece, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overview of Number of Participants With Adverse Events | Numbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (=) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (=) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study | Baseline up to approximately 25 months | |
Primary | Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12 | The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline | Baseline, 6 and 12 months | |
Primary | Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12 | The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline | Baseline, 6 and 12 months | |
Primary | Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12 | The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline | Baseline, 6 and 12 months | |
Primary | Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12 | The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline | Baseline, 6 and 12 months | |
Primary | Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12 | The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline | Baseline, 6 and 12 months | |
Primary | Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12 | The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline | Baseline, 6 and 12 months | |
Primary | Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12 | The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline | Baseline, 6 and 12 months | |
Secondary | Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12 | The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline. A negative change from baseline is regarded as an improvement in this study | Baseline, 6 and 12 months | |
Secondary | Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12 | The percentage relative change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Percentage relative change = 100 × ([Post - Baseline] / Baseline). Percentage relative change is calculated for each patient individually and then overall descriptive summary statistics is obtained for subjects with a value at baseline and the particular time point. A negative percentage relative change from baseline is regarded as an improvement in this study | Baseline, 6 and 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05440487 -
Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload
|
||
Completed |
NCT01825512 -
Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients
|
Phase 3 | |
Completed |
NCT06215287 -
Survey to Assess Physicians' Knowledge of Exjade Posology and Biological Monitoring Recommendations as Described in the Educational Materials
|
||
Completed |
NCT01740713 -
Pharmacokinetic Study of Deferiprone in Paediatric Patients
|
Phase 2 |