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Trial record 1 of 1 for:    NCT00146757
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A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years Old

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ClinicalTrials.gov Identifier: NCT00146757
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : June 16, 2009
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
BioMarin/Genzyme LLC
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mucopolysaccharidosis I
Hurler Syndrome
Hurler-Scheie Syndrome
Scheie Syndrome
Intervention Biological: Aldurazyme (Recombinant Human Alpha-L-Iduronidase)
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aldurazyme (rhIDU) 100 U/kg Every Week Aldurazyme (rhIDU) 100-200 U/kg Every Week
Hide Arm/Group Description Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose. After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
Period Title: Overall Study
Started 16 4
Completed 14 4
Not Completed 2 0
Reason Not Completed
Death             1             0
Adverse Event             1             0
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
2.9  (1.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Caucasian 18
Black 1
Other 1
1.Primary Outcome
Title Safety Evaluation
Hide Description Overall Safety Summary of Adverse Events (AEs) during Treatment Safety assessment was based on the incidence of AE reports.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was determined as adequate to assess the safety of Aldurazyme in young children with mucopolysaccharidosis I (MPS I). The analysis was intent-to-treat.
Arm/Group Title Aldurazyme (rhIDU) 100 U/kg Every Week Aldurazyme (rhIDU) 100-200 U/kg Every Week
Hide Arm/Group Description:
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
Overall Number of Participants Analyzed 16 4
Measure Type: Number
Unit of Measure: participants
Having Adverse Events (AE) 16 4
Having Drug-Related AEs 5 3
Deaths/Discontinuations Due to AEs 2 0
Having Serious AEs 12 3
Having Severe AEs 5 1
Having Infusion Associated Reactions (IAR): 4 3
2.Primary Outcome
Title Pharmacokinetics - Area Under the (Plasma Concentration-time) Curve (AUC∞)
Hide Description AUC∞ is a measure of the total exposure to a drug.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: hours units/milliliters
Week 1 0.577  (0.591)
Week 13 0.418  (0.246)
Week 26 0.92  (0.68)
Week 52 0.94  (0.97)
3.Primary Outcome
Title Pharmacokinetics - Elimination Half Life (t1/2)
Hide Description Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: hours
Week 1 1.55  (0.516)
Week 13 0.55  (0.284)
Week 26 0.946  (0.877)
Week 52 1.147  (0.87)
4.Primary Outcome
Title Pharmacokinetics - Total Plasma Clearance (CL)
Hide Description CL is volume of the body fluid cleared of the drug per unit of time.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: (milliliters/minute)/kilograms
Week 1 5.73  (3.90)
Week 13 5.33  (2.67)
Week 26 2.97  (1.87)
Week 52 3.20  (2.02)
5.Primary Outcome
Title Pharmacokinetics - Volume of Distribution (Vz)
Hide Description Vz is the volume that relates the amount of drug in the body after absorption is complete to the concentration of drug in the plasma.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: liters/kilograms
Week 1 0.753  (0.497)
Week 13 0.299  (0.303)
Week 26 0.214  (0.297)
Week 52 0.246  (0.210)
6.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 52 in Urinary Glycosaminoglycan (uGAG) Level
Hide Description Percentage change in the concentration of GAG relative to creatinine (ug GAG/mg creatinine) in urine from Baseline to Week 52; A greater decrease in percent change indicates a greater response.
Time Frame Baseline to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Aldurazyme (rhIDU) 100 U/kg Every Week Aldurazyme (rhIDU) 100-200 U/kg Every Week
Hide Arm/Group Description:
Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
Overall Number of Participants Analyzed 12 4
Mean (Standard Deviation)
Unit of Measure: Percentage of change
-59.1  (21.41) -67.7  (14.21)
7.Other Pre-specified Outcome
Title Percent Change From Baseline to Week 52 in Liver Size (Hepatomegaly)
Hide Description Percent change in extent of Liver Edge Below Right Costal Margin (BRCM) measured in centimeters from Baseline to Week 52; A greater decrease in percent change indicates a greater response.
Time Frame Baseline to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Percentage of change
-69.5  (15.34)
8.Other Pre-specified Outcome
Title Change From Baseline to Week 52 in Apnea/Hypopnea Index (AHI)
Hide Description Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. A greater decrease in events per hour indicates a greater response.
Time Frame Baseline to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Events per hour
-2.6  (22.27)
9.Other Pre-specified Outcome
Title Expert Global Assessment of Sleep Study Results at Week 52 Compared With Baseline
Hide Description Independent experts provided a global assessment for each sleep study visit as well as the degree of clinically meaningful change over the course of the study. Assessment was based on AHI, severity and frequency of oxygen desaturations and sleep quality.
Time Frame Baseline to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Marked Improvement 1
Moderate Improvement 3
Mild Improvement 1
No change 5
Slight Worsening 3
Moderate Worsening 1
Marked Worsening 1
10.Other Pre-specified Outcome
Title Change From Baseline to Week 52 in Left Ventricular Mass (LVM) Z-Score
Hide Description Change in LVM Z-scores as measured by echocardiography from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.
Time Frame Baseline to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.9  (1.58)
11.Other Pre-specified Outcome
Title Change From Baseline to Week 52 in Height
Hide Description Change in Z-scores for standing height/lying-length-for-age from Baseline to Week 52. Z-score=number of standard deviations from mean. Z-scores greater than +2 and less than -2 are abnormal. A greater decrease in abnormally high z-score indicates a greater response.
Time Frame Baseline to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.5  (0.93)
12.Other Pre-specified Outcome
Title Investigator’s Clinical Assessment at Week 52 Compared With Baseline
Hide Description The Investigator’s impression of the patient’s overall clinical status at Week 52 compared with Baseline.
Time Frame Baseline to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was intent-to-treat.
Arm/Group Title Arms 1 and 2 Combined
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Marked Improvement 0
Moderate Improvement 6
Mild Improvement 11
No Change 1
Slight Worsening 0
Moderate Worsening 0
Marked Worsening 0
Time Frame [Not Specified]
Adverse Event Reporting Description In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
 
Arm/Group Title Aldurazyme ***Check Title***
Hide Arm/Group Description Aldurazyme ***check title***
All-Cause Mortality
Aldurazyme ***Check Title***
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aldurazyme ***Check Title***
Affected / at Risk (%)
Total   15/20 (75.00%) 
Cardiac disorders   
Cardiac failure  1  1/20 (5.00%) 
Cyanosis  1  1/20 (5.00%) 
Tachycardia  1  1/20 (5.00%) 
Congenital, familial and genetic disorders   
Hip dysplasia  1  2/20 (10.00%) 
Gastrointestinal disorders   
Dental caries  1  1/20 (5.00%) 
Inguinal hernia  1  1/20 (5.00%) 
Umbilical hernia  1  1/20 (5.00%) 
General disorders   
Catheter related complication  1  1/20 (5.00%) 
Pyrexia  1  1/20 (5.00%) 
Infections and infestations   
Ear infection  1  2/20 (10.00%) 
Gastroenteritis  1  1/20 (5.00%) 
Lower respiratory tract infection  1  2/20 (10.00%) 
Otitis media  1  4/20 (20.00%) 
Pharyngitis  1  1/20 (5.00%) 
Post procedural infection  1  1/20 (5.00%) 
Respiratory syncytial virus infection  1  1/20 (5.00%) 
Injury, poisoning and procedural complications   
Endotracheal intubation complication  1  1/20 (5.00%) 
Postoperative respiratory distress  1  1/20 (5.00%) 
Subdural haematoma  1  2/20 (10.00%) 
Investigations   
Blood pressure increased  1  1/20 (5.00%) 
Medical observation  1  1/20 (5.00%) 
Oxygen saturation decreased  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Arthropathy  1  1/20 (5.00%) 
Nervous system disorders   
Cerebral haemorrhage  1  1/20 (5.00%) 
Convulsion  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Adenoidal disorder  1  1/20 (5.00%) 
Adenoidal hypertrophy  1  1/20 (5.00%) 
Aspiration  1  1/20 (5.00%) 
Asthma  1  1/20 (5.00%) 
Atelectasis  1  1/20 (5.00%) 
Laryngeal oedema  1  1/20 (5.00%) 
Respiratory arrest  1  1/20 (5.00%) 
Sleep apnoea syndrome  1  1/20 (5.00%) 
Tonsillar hypertrophy  1  2/20 (10.00%) 
Surgical and medical procedures   
Adenotonsillectomy  1  1/20 (5.00%) 
Catheterisation venous  1  1/20 (5.00%) 
Central venous catheterisation  1  3/20 (15.00%) 
Ear tube insertion  1  1/20 (5.00%) 
Ear tube removal  1  1/20 (5.00%) 
Vascular disorders   
Poor venous access  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aldurazyme ***Check Title***
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia  1  1/20 (5.00%) 
Lymphadenopathy  1  2/20 (10.00%) 
Cardiac disorders   
Angina pectoris  1  1/20 (5.00%) 
Aortic valve disease  1  1/20 (5.00%) 
Aortic valve incompetence  1  2/20 (10.00%) 
Mitral valve incompetence  1  1/20 (5.00%) 
Tachycardia  1  1/20 (5.00%) 
Ear and labyrinth disorders   
Cerumen impaction  1  2/20 (10.00%) 
Ear congestion  1  1/20 (5.00%) 
Ear pain  1  4/20 (20.00%) 
Ear pruritus  1  1/20 (5.00%) 
Otorrhoea  1  10/20 (50.00%) 
Eye disorders   
Conjunctivitis  1  3/20 (15.00%) 
Eye discharge  1  1/20 (5.00%) 
Lacrimation increased  1  1/20 (5.00%) 
Ocular hypertension  1  1/20 (5.00%) 
Strabismus  1  1/20 (5.00%) 
Gastrointestinal disorders   
Abdominal pain  1  2/20 (10.00%) 
Abdominal pain upper  1  2/20 (10.00%) 
Constipation  1  1/20 (5.00%) 
Diarrhoea  1  17/20 (85.00%) 
Faecal incontinence  1  1/20 (5.00%) 
Inguinal hernia  1  1/20 (5.00%) 
Lip haematoma  1  1/20 (5.00%) 
Nausea  1  1/20 (5.00%) 
Retching  1  1/20 (5.00%) 
Teething  1  1/20 (5.00%) 
Toothache  1  2/20 (10.00%) 
Umbilical hernia  1  1/20 (5.00%) 
Vomiting  1  14/20 (70.00%) 
General disorders   
Adverse drug reaction  1  1/20 (5.00%) 
Catheter related complication  1  1/20 (5.00%) 
Catheter site discharge  1  1/20 (5.00%) 
Catheter site swelling  1  4/20 (20.00%) 
Chills  1  4/20 (20.00%) 
Crepitations  1  1/20 (5.00%) 
Cyst  1  1/20 (5.00%) 
Facial pain  1  1/20 (5.00%) 
Fatigue  1  2/20 (10.00%) 
Feeling hot  1  2/20 (10.00%) 
Gait disturbance  1  1/20 (5.00%) 
Inflammation  1  1/20 (5.00%) 
Oedema peripheral  1  1/20 (5.00%) 
Pain  1  1/20 (5.00%) 
Pyrexia  1  20/20 (100.00%) 
Infections and infestations   
Abscess  1  1/20 (5.00%) 
Bacterial disease carrier  1  1/20 (5.00%) 
Bacterial infection  1  1/20 (5.00%) 
Bronchitis  1  7/20 (35.00%) 
Candida nappy rash  1  1/20 (5.00%) 
Conjunctivitis infective  1  1/20 (5.00%) 
Ear infection  1  5/20 (25.00%) 
Eye infection  1  2/20 (10.00%) 
Fungal infection  1  1/20 (5.00%) 
Gastroenteritis  1  6/20 (30.00%) 
Gingival abscess  1  1/20 (5.00%) 
Lower respiratory tract infection  1  1/20 (5.00%) 
Nasopharyngitis  1  8/20 (40.00%) 
Oral candidiasis  1  1/20 (5.00%) 
Oral herpes  1  1/20 (5.00%) 
Otitis externa  1  1/20 (5.00%) 
Otitis media  1  2/20 (10.00%) 
Paronychia  1  1/20 (5.00%) 
Pharyngitis  1  2/20 (10.00%) 
Rhinitis  1  11/20 (55.00%) 
Rubella  1  1/20 (5.00%) 
Upper respiratory tract infection  1  3/20 (15.00%) 
Urinary tract infection  1  1/20 (5.00%) 
Varicella  1  1/20 (5.00%) 
Injury, poisoning and procedural complications   
Contusion  1  1/20 (5.00%) 
Ear injury  1  1/20 (5.00%) 
Excoriation  1  1/20 (5.00%) 
Face injury  1  1/20 (5.00%) 
Fall  1  3/20 (15.00%) 
Gingival injury  1  1/20 (5.00%) 
Head injury  1  1/20 (5.00%) 
Laceration  1  1/20 (5.00%) 
Mouth injury  1  2/20 (10.00%) 
Procedural pain  1  1/20 (5.00%) 
Skin laceration  1  1/20 (5.00%) 
Subdural haematoma  1  1/20 (5.00%) 
Wound  1  2/20 (10.00%) 
Investigations   
Bacterial culture positive  1  1/20 (5.00%) 
Blood iron decreased  1  3/20 (15.00%) 
Blood pressure decreased  1  1/20 (5.00%) 
Blood pressure increased  1  1/20 (5.00%) 
Body temperature increased  1  1/20 (5.00%) 
Breath sounds abnormal  1  1/20 (5.00%) 
Cardiac murmur  1  1/20 (5.00%) 
Haemoglobin decreased  1  1/20 (5.00%) 
Heart rate increased  1  1/20 (5.00%) 
Lymph node palpable  1  1/20 (5.00%) 
Oxygen saturation decreased  1  3/20 (15.00%) 
Platelet count increased  1  1/20 (5.00%) 
Urine analysis abnormal  1  1/20 (5.00%) 
White blood cell count increased  1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Fluid intake reduced  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/20 (10.00%) 
Arthropathy  1  1/20 (5.00%) 
Flank pain  1  1/20 (5.00%) 
Muscle spasms  1  1/20 (5.00%) 
Muscle twitching  1  1/20 (5.00%) 
Pain in extremity  1  3/20 (15.00%) 
Nervous system disorders   
Head discomfort  1  1/20 (5.00%) 
Headache  1  3/20 (15.00%) 
Hemiparesis  1  1/20 (5.00%) 
Hyperreflexia  1  1/20 (5.00%) 
Lethargy  1  3/20 (15.00%) 
Psychiatric disorders   
Listless  1  1/20 (5.00%) 
Restlessness  1  2/20 (10.00%) 
Self-induced vomiting  1  1/20 (5.00%) 
Renal and urinary disorders   
Dysuria  1  1/20 (5.00%) 
Urinary incontinence  1  1/20 (5.00%) 
Reproductive system and breast disorders   
Pruritus genital  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/20 (5.00%) 
Bronchial hyperreactivity  1  1/20 (5.00%) 
Cough  1  17/20 (85.00%) 
Dyspnoea  1  1/20 (5.00%) 
Nasal congestion  1  3/20 (15.00%) 
Oropharyngeal pain  1  1/20 (5.00%) 
Pharyngeal erythema  1  1/20 (5.00%) 
Pneumonia aspiration  1  1/20 (5.00%) 
Productive cough  1  2/20 (10.00%) 
Respiratory distress  1  1/20 (5.00%) 
Rhinorrhoea  1  12/20 (60.00%) 
Sleep apnoea syndrome  1  1/20 (5.00%) 
Sneezing  1  2/20 (10.00%) 
Upper airway obstruction  1  2/20 (10.00%) 
Wheezing  1  2/20 (10.00%) 
Skin and subcutaneous tissue disorders   
Dermatitis diaper  1  2/20 (10.00%) 
Dry skin  1  1/20 (5.00%) 
Eczema  1  2/20 (10.00%) 
Erythema  1  2/20 (10.00%) 
Heat rash  1  2/20 (10.00%) 
Pain of skin  1  1/20 (5.00%) 
Pruritus  1  1/20 (5.00%) 
Rash  1  10/20 (50.00%) 
Rash macular  1  2/20 (10.00%) 
Swelling face  1  1/20 (5.00%) 
Urticaria  1  1/20 (5.00%) 
Vascular disorders   
Haematoma  1  3/20 (15.00%) 
Hypertension  1  1/20 (5.00%) 
Pallor  1  1/20 (5.00%) 
Vein disorder  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Due to the rarity of the disease, this study is limited by its small sample size and lack of a control group.
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.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00146757     History of Changes
Other Study ID Numbers: ALID-014-02
First Submitted: September 2, 2005
First Posted: September 7, 2005
Results First Submitted: November 20, 2008
Results First Posted: June 16, 2009
Last Update Posted: April 3, 2015