Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00447694
Collaborator
(none)
30
Enrollment
3
Locations
1
Arm
45
Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Trial Evaluating Cardiac T2* in Beta-thalassemia Patients on Deferasirox (ICL670) Treatment for 18 Months
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Experimental: deferasirox every day for 77 weeks

Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.

Drug: Deferasirox
Oral deferasirox 30mg/kg/day once per day for 77 weeks.

Outcome Measures

Primary Outcome Measures

  1. Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* [From Baseline to 25, 49, 77 Week]

    Cardiac T2* was measured in the short axis plane at the widest point of a 4-chamber localizer using custom breath-hold R2* gradient echo sequences modeled after techniques used by Anderson et al (2001) and Westwood et al (2003).

Secondary Outcome Measures

  1. Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks [From Baseline to 25, 49, 77 Week]

    MRI evaluation of liver iron concentration has been validated by liver biopsy (St Pierre et al 2005). Studies comparing T2* values of liver iron concentration (LIC) with LIC as assessed by biopsy have confirmed that T2* values reflect liver iron content (Wood et al 2003b). Direct tissue-validation of cardiac T2* measurements in humans has not been performed because endomyocardial biopsy is a dangerous and unreliable indicator of cardiac iron overload (Olson et al 1989, Fitchett et al 1980). However, it has been shown that cardiac T2* accurately reflects cardiac iron in a gerbil iron cardiomyopathy model (Wood et al 2004b). T2* measurements have shown excellent inter-scanner and inter-exam reproducibility, making them suitable for longitudinal monitoring (Westwood et al 2003a, Westwood et al 2003b).

  2. Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks [From Baseline to 25, 49, 77 Week]

    Magnetic resonance imaging (MRI)-measured cardiac T2* and cardiac function reflected by left and right ventricle ejection fraction. A standardized MRI protocol for T2* acquisition technique will be used in the centers. Images will be reviewed centrally by an expert MRI reader.

  3. Serum Ferritin and Changes From Baseline in Serum Ferritin During Study [From Baseline to 25, 49, 77 Week]

    Serum ferritin will be assessed at each study visit. Analysis was performed in Completer population consists of those participants who had a Week 77 MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male or female β-thalassemia outpatients on chronic transfusion therapy (defined as > 8 transfusions per year)

  • Lifetime minimum of 100 previous packed red blood cell transfusions

  • Patients currently on chelation therapy will require a one day wash out prior to the first dose of study drug

  • Age ≥ 10 years

  • Sexually active females of childbearing potential must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy.

Exclusion Criteria:
  • Ejection Fraction < 56 % measured using steady-state free precession imaging by MRI

  • Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia

  • Abnormal laboratory values as defined by the protocol

  • Clinical or laboratory evidence of active Hepatitis B or Hepatitis C

  • History of HIV positive test result (ELISA or Western blot)

  • Uncontrolled systemic hypertension

  • Second or third degree A-V block

  • Life-threatening arrhythmias, including sustained ventricular tachycardia and aborted sudden death, within the last year

  • History of cardiac conditions or unstable cardiac disease not controlled by standard medical therapy

  • History of clinically relevant ocular toxicity related to iron chelation

  • Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment

  • Pregnancy or breast feeding (documented negative pregnancy test required for study entry)

  • Patients enrolled in an ongoing clinical trial of deferasirox (ICL670) cannot be withdrawn in order to participate in this study

  • Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days

  • Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug

  • History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative

  • Other inclusion/exclusion criteria may apply

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Childrens Hospital of Los AngelesLos AngelesCaliforniaUnited States90027
2Children's Hospital and Research Center at OaklandOaklandCaliforniaUnited States94609
3Children's Memorial HospitalChicagoIllinoisUnited States60614

Sponsors and Collaborators

  • Novartis

Investigators

  • Principal Investigator: Thomas Coates, MD, Childresn's Hospital of Los Angeles
  • Principal Investigator: Alexis Thompson, MD, Children's Memorial Hospital of Chicago
  • Principal Investigator: Paul Harmatz, MD, Children's Hospital and Research Center at Oakland

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00447694
Other Study ID Numbers:
  • CICL670AUS04
First Posted:
Mar 15, 2007
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021

Study Results

Participant Flow

Recruitment DetailsThe study was conducted at 4 centers in the United States
Pre-assignment DetailA total number of participants planned for this study was 30. The total number of 28 participants enrolled in the study, of these 22 completed the study and 6 discontinued the study.
Arm/Group TitleDeferasirox
Arm/Group DescriptionParticipants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Period Title: Overall Study
STARTED28
COMPLETED22
NOT COMPLETED6

Baseline Characteristics

Arm/Group TitleDeferasirox
Arm/Group DescriptionParticipants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Overall Participants28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
22.6
(8.67)
Sex: Female, Male (Count of Participants)
Female
20
71.4%
Male
8
28.6%
Race/Ethnicity, Customized (participants) [Number]
Caucasian
9
32.1%
Black
0
0%
Oriental
7
25%
Other
12
42.9%

Outcome Measures

1. Primary Outcome
TitleMagnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2*
DescriptionCardiac T2* was measured in the short axis plane at the widest point of a 4-chamber localizer using custom breath-hold R2* gradient echo sequences modeled after techniques used by Anderson et al (2001) and Westwood et al (2003).
Time FrameFrom Baseline to 25, 49, 77 Week

Outcome Measure Data

Analysis Population Description
The analysis was performed in Completer population (CP) consists of those participants who had a Week 77 MRI.
Arm/Group TitleDeferasirox
Arm/Group DescriptionParticipants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Measure Participants22
Baseline
9.92
(3.922)
Week 25
11.73
(6.091)
Week 25 Absolute Change from Baseline
1.77
(3.203)
Week 49
11.93
(6.489)
Week 49 Absolute Change from Baseline
2.01
(3.792)
Week 77
12.10
(6.461)
Week 77 Absolute Change from Baseline
2.18
(3.927)
2. Secondary Outcome
TitleChange From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks
DescriptionMRI evaluation of liver iron concentration has been validated by liver biopsy (St Pierre et al 2005). Studies comparing T2* values of liver iron concentration (LIC) with LIC as assessed by biopsy have confirmed that T2* values reflect liver iron content (Wood et al 2003b). Direct tissue-validation of cardiac T2* measurements in humans has not been performed because endomyocardial biopsy is a dangerous and unreliable indicator of cardiac iron overload (Olson et al 1989, Fitchett et al 1980). However, it has been shown that cardiac T2* accurately reflects cardiac iron in a gerbil iron cardiomyopathy model (Wood et al 2004b). T2* measurements have shown excellent inter-scanner and inter-exam reproducibility, making them suitable for longitudinal monitoring (Westwood et al 2003a, Westwood et al 2003b).
Time FrameFrom Baseline to 25, 49, 77 Week

Outcome Measure Data

Analysis Population Description
The analysis was performed in Completer population consists of those participants who had a Week 77 MRI.
Arm/Group TitleDeferasirox
Arm/Group DescriptionParticipants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Measure Participants22
Baseline
19.85
(3.309)
Week 25
17.23
(15.393)
Week 25 Absolute Change from Baseline
-2.89
(4.169)
Week 49
17.0
(17.548)
Week 49 Absolute Change from Baseline
-2.85
(4.883)
Week 77
16.62
(20.114)
Week 77 Absolute Change from Baseline
-3.23
(7.708)
3. Secondary Outcome
TitleLeft Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks
DescriptionMagnetic resonance imaging (MRI)-measured cardiac T2* and cardiac function reflected by left and right ventricle ejection fraction. A standardized MRI protocol for T2* acquisition technique will be used in the centers. Images will be reviewed centrally by an expert MRI reader.
Time FrameFrom Baseline to 25, 49, 77 Week

Outcome Measure Data

Analysis Population Description
The analysis was performed in Completer population consisting of those participants who had a Week 77 MRI.
Arm/Group TitleDeferasirox
Arm/Group DescriptionParticipants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Measure Participants22
Baseline
64.01
(6.751) 228.6%
Week 25
62.17
(6.352) 222%
Week 25 Absolute change from baseline
-1.84
(7.306) -6.6%
Week 49
61.61
(13.726) 220%
Week 49 Absolute change from baseline
-2.68
(14.546) -9.6%
Week 77
63.84
(6.112) 228%
Week 77 Absolute change from baseline
0.11
(7.299) 0.4%
4. Secondary Outcome
TitleSerum Ferritin and Changes From Baseline in Serum Ferritin During Study
DescriptionSerum ferritin will be assessed at each study visit. Analysis was performed in Completer population consists of those participants who had a Week 77 MRI.
Time FrameFrom Baseline to 25, 49, 77 Week

Outcome Measure Data

Analysis Population Description
The analysis was performed in Completer population consists of those participants who had a Week 77 MRI.
Arm/Group TitleDeferasirox
Arm/Group DescriptionParticipants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Measure Participants22
Baseline
4343.75
(3486.525)
Week 25
4280.77
(5261.563)
Week 25 Absolute change from baseline
-62.98
(2294.635)
Week 49
3759.29
(3966.107)
Week 49 Absolute change from baseline
-593.36
(1534.040)
Week 77
3179.81
(3439.357)
Week 77 Absolute change from baseline
-882.74
(1368.202)

Adverse Events

Time FrameAdverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77.
Adverse Event Reporting Description The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Arm/Group TitleAll Patients
Arm/Group DescriptionParticipants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
All Cause Mortality
All Patients
Affected / at Risk (%)# Events
Total0/27 (0%)
Serious Adverse Events
All Patients
Affected / at Risk (%)# Events
Total8/27 (29.6%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation1/27 (3.7%)
Thrombocytopenia1/27 (3.7%)
Cardiac disorders
Arrhythmia1/27 (3.7%)
Cardiac failure1/27 (3.7%)
Tachycardia1/27 (3.7%)
Congenital, familial and genetic disorders
Fanconi syndrome1/27 (3.7%)
Gastrointestinal disorders
Abdominal compartment syndrome1/27 (3.7%)
Abdominal pain4/27 (14.8%)
Ascites1/27 (3.7%)
Colitis1/27 (3.7%)
Gastrointestinal oedema1/27 (3.7%)
Nausea1/27 (3.7%)
Pancreatitis1/27 (3.7%)
Vomiting3/27 (11.1%)
General disorders
Multi-organ failure1/27 (3.7%)
Pyrexia5/27 (18.5%)
Hepatobiliary disorders
Hepatic failure1/27 (3.7%)
Hepatic steatosis1/27 (3.7%)
Hepatitis1/27 (3.7%)
Infections and infestations
Aspergillosis1/27 (3.7%)
Bacterial infection1/27 (3.7%)
Bronchitis viral1/27 (3.7%)
Herpes simplex1/27 (3.7%)
Pneumonia1/27 (3.7%)
Sepsis1/27 (3.7%)
Septic shock1/27 (3.7%)
Urinary tract infection1/27 (3.7%)
Urinary tract infection fungal1/27 (3.7%)
Injury, poisoning and procedural complications
Fibula fracture1/27 (3.7%)
Splenic rupture1/27 (3.7%)
Tibia fracture1/27 (3.7%)
Investigations
Blood creatinine increased1/27 (3.7%)
Blood phosphorus decreased1/27 (3.7%)
Ejection fraction decreased1/27 (3.7%)
Urine analysis abnormal1/27 (3.7%)
Metabolism and nutrition disorders
Acidosis1/27 (3.7%)
Acidosis hyperchloraemic1/27 (3.7%)
Anorexia1/27 (3.7%)
Dehydration2/27 (7.4%)
Hyperglycaemia1/27 (3.7%)
Musculoskeletal and connective tissue disorders
Back pain1/27 (3.7%)
Nervous system disorders
Depressed level of consciousness1/27 (3.7%)
Unresponsive to stimuli1/27 (3.7%)
Psychiatric disorders
Mental status changes1/27 (3.7%)
Psychotic disorder1/27 (3.7%)
Renal and urinary disorders
Azotaemia1/27 (3.7%)
Polyuria1/27 (3.7%)
Renal failure1/27 (3.7%)
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain1/27 (3.7%)
Pulmonary oedema1/27 (3.7%)
Respiratory failure1/27 (3.7%)
Vascular disorders
Hypoperfusion1/27 (3.7%)
Hypotension2/27 (7.4%)
Shock1/27 (3.7%)
Other (Not Including Serious) Adverse Events
All Patients
Affected / at Risk (%)# Events
Total27/27 (100%)
Cardiac disorders
Left atrial dilatation1/27 (3.7%)
Left ventricular hypertrophy2/27 (7.4%)
Sinus bradycardia1/27 (3.7%)
Sinus tachycardia1/27 (3.7%)
Tachycardia2/27 (7.4%)
Ear and labyrinth disorders
Vertigo1/27 (3.7%)
Eye disorders
Conjunctivitis1/27 (3.7%)
Conjunctivitis allergic1/27 (3.7%)
Dry eye1/27 (3.7%)
Eye irritation1/27 (3.7%)
Gastrointestinal disorders
Abdominal pain7/27 (25.9%)
Abdominal pain lower1/27 (3.7%)
Constipation2/27 (7.4%)
Diarrhoea12/27 (44.4%)
Dyspepsia1/27 (3.7%)
Gastritis1/27 (3.7%)
Nausea16/27 (59.3%)
Vomiting6/27 (22.2%)
General disorders
Chest discomfort3/27 (11.1%)
Chills2/27 (7.4%)
Fatigue9/27 (33.3%)
Non-cardiac chest pain1/27 (3.7%)
Oedema1/27 (3.7%)
Oedema peripheral1/27 (3.7%)
Pain2/27 (7.4%)
Pyrexia10/27 (37%)
Hepatobiliary disorders
Cholelithiasis1/27 (3.7%)
Immune system disorders
House dust allergy1/27 (3.7%)
Infections and infestations
Candidiasis1/27 (3.7%)
Ear infection1/27 (3.7%)
Folliculitis1/27 (3.7%)
Fungal infection1/27 (3.7%)
Hordeolum1/27 (3.7%)
Nasopharyngitis11/27 (40.7%)
Oral herpes1/27 (3.7%)
Pharyngitis1/27 (3.7%)
Sinusitis3/27 (11.1%)
Upper respiratory tract infection4/27 (14.8%)
Urinary tract infection2/27 (7.4%)
Vulvovaginal mycotic infection2/27 (7.4%)
Injury, poisoning and procedural complications
Animal bite1/27 (3.7%)
Arthropod bite1/27 (3.7%)
Arthropod sting1/27 (3.7%)
Clavicle fracture1/27 (3.7%)
Contusion1/27 (3.7%)
Excoriation2/27 (7.4%)
Joint injury1/27 (3.7%)
Thoracic vertebral fracture1/27 (3.7%)
Wrist fracture1/27 (3.7%)
Investigations
Alanine aminotransferase increased2/27 (7.4%)
Aspartate aminotransferase increased2/27 (7.4%)
Blood 1,25-dihydroxycholecalciferol decreased1/27 (3.7%)
Blood creatinine increased2/27 (7.4%)
Ejection fraction decreased1/27 (3.7%)
Electrocardiogram ST-T change2/27 (7.4%)
Hepatic enzyme increased1/27 (3.7%)
Transaminases increased1/27 (3.7%)
Urine albumin/creatinine ratio abnormal1/27 (3.7%)
Urine albumin/creatinine ratio increased1/27 (3.7%)
Urine output decreased2/27 (7.4%)
Weight decreased1/27 (3.7%)
Metabolism and nutrition disorders
Alkalosis1/27 (3.7%)
Anorexia1/27 (3.7%)
Carnitine deficiency2/27 (7.4%)
Copper deficiency1/27 (3.7%)
Decreased appetite1/27 (3.7%)
Dehydration1/27 (3.7%)
Hyperglycaemia2/27 (7.4%)
Hyperkalaemia1/27 (3.7%)
Hypocalcaemia1/27 (3.7%)
Hypoglycaemia1/27 (3.7%)
Hypokalaemia1/27 (3.7%)
Selenium deficiency1/27 (3.7%)
Vitamin A deficiency1/27 (3.7%)
Vitamin B complex deficiency3/27 (11.1%)
Vitamin B1 deficiency1/27 (3.7%)
Vitamin B12 deficiency1/27 (3.7%)
Vitamin B6 deficiency1/27 (3.7%)
Vitamin C deficiency1/27 (3.7%)
Vitamin D deficiency5/27 (18.5%)
Vitamin E deficiency1/27 (3.7%)
Zinc deficiency2/27 (7.4%)
Musculoskeletal and connective tissue disorders
Arthralgia6/27 (22.2%)
Back pain3/27 (11.1%)
Bone pain1/27 (3.7%)
Extremity contracture1/27 (3.7%)
Flank pain1/27 (3.7%)
Joint range of motion decreased1/27 (3.7%)
Myalgia2/27 (7.4%)
Neck pain1/27 (3.7%)
Osteopenia1/27 (3.7%)
Pain in extremity3/27 (11.1%)
Nervous system disorders
Basal ganglion degeneration1/27 (3.7%)
Dizziness5/27 (18.5%)
Headache9/27 (33.3%)
Hypoaesthesia1/27 (3.7%)
Paraesthesia1/27 (3.7%)
Psychiatric disorders
Insomnia1/27 (3.7%)
Renal and urinary disorders
Chromaturia1/27 (3.7%)
Dysuria1/27 (3.7%)
Reproductive system and breast disorders
Dysmenorrhoea1/27 (3.7%)
Respiratory, thoracic and mediastinal disorders
Asthma1/27 (3.7%)
Cough10/27 (37%)
Dyspnoea1/27 (3.7%)
Nasal congestion4/27 (14.8%)
Pharyngolaryngeal pain3/27 (11.1%)
Postnasal drip1/27 (3.7%)
Respiratory tract congestion1/27 (3.7%)
Wheezing1/27 (3.7%)
Skin and subcutaneous tissue disorders
Dermatitis contact1/27 (3.7%)
Ingrown hair1/27 (3.7%)
Rash7/27 (25.9%)
Skin irritation1/27 (3.7%)
Urticaria3/27 (11.1%)
Surgical and medical procedures
Wisdom teeth removal1/27 (3.7%)
Vascular disorders
Hypertension1/27 (3.7%)
Hypotension2/27 (7.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleStudy Director
OrganizationNovartis Pharmaceuticals
Phone862-778-8300
EmailNovartis.email@novartis.com
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00447694
Other Study ID Numbers:
  • CICL670AUS04
First Posted:
Mar 15, 2007
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021