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Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease

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.
 
ClinicalTrials.gov Identifier: NCT00553631
Recruitment Status : Completed
First Posted : November 4, 2007
Results First Posted : January 4, 2011
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gaucher Disease, Type 1
Interventions Biological: velaglucerase alfa
Biological: imiglucerase
Enrollment 34
Recruitment Details The study was conducted in multiple sites from 29 January 2008 (first participant first enrolled) to 05 May 2009 (last participant completed).
Pre-assignment Details Participants at least 2 years of age with type 1 Gaucher disease.Gaucher-disease-related anemia and at least 1 of the following: moderate splenomegaly, Gaucher-disease-related thrombocytopenia, readily palpable enlarged liver. Participants had not received treatment for Gaucher disease within 12 months prior to study entry.
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description Velaglucerase alfa 60 unit per kilogram (U/kg) administered intravenously (IV) every other week for 39 weeks. Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Period Title: Overall Study
Started 17 [1] 17 [1]
Completed 16 16
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             1             0
[1]
Intent-to-treat (ITT) population
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase Total
Hide Arm/Group Description Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks. Imiglucerase 60 U/kg administered IV every other week for 39 weeks. Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
<=18 years
4
  23.5%
5
  29.4%
9
  26.5%
Between 18 and 65 years
13
  76.5%
11
  64.7%
24
  70.6%
>=65 years
0
   0.0%
1
   5.9%
1
   2.9%
[1]
Measure Description: Age at time of consent
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
36
(7 to 60)
27
(3 to 73)
30.5
(3 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
9
  52.9%
9
  52.9%
18
  52.9%
Male
8
  47.1%
8
  47.1%
16
  47.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
United States 0 1 1
Paraguay 3 2 5
Argentina 2 1 3
Spain 1 2 3
Israel 1 2 3
Russian Federation 2 2 4
Tunisia 4 2 6
United Kingdom 0 1 1
India 4 4 8
1.Primary Outcome
Title Mean Change From Baseline to Month 9 in Hemoglobin (Hgb) Concentration for Each Treatment Group.
Hide Description [Not Specified]
Time Frame Baseline to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population comprised of all randomized participants who received at least 1 full or partial dose of study drug.
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description:
Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Overall Number of Participants Analyzed 17 17
Mean (Standard Error)
Unit of Measure: gram per deciliter (g/dl)
1.624  (0.223) 1.488  (0.281)
2.Secondary Outcome
Title Change From Baseline to Month 9 in Platelet Counts for Each Treatment Group.
Hide Description Values shown are observed change from Baseline to Month 9.
Time Frame Baseline to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description:
Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Overall Number of Participants Analyzed 17 17
Mean (Standard Error)
Unit of Measure: 10^9 per liter (10^9/L)
110.41  (17.159) 144.38  (22.76)
3.Secondary Outcome
Title Change From Baseline to Month 9 in Normalized Liver Volume (Percent (%) Body Weight) for Each Treatment Group.
Hide Description Values shown are observed change from Baseline to Month 9. Measured by Magnetic resonance imaging (MRI). Liver volume has been normalized for percent (%) body weight for each treatment arm. Liver size relative to body weight = (Liver volume [cubic centimeter (cc)]/Body weight [kg]*1000.
Time Frame Baseline to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description:
Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Overall Number of Participants Analyzed 17 17
Mean (Standard Error)
Unit of Measure: cubic centimeter (cm^3)
-1.31  (0.347) -1.10  (0.182)
4.Secondary Outcome
Title Change From Baseline to Month 9 in Normalized Spleen Volume (Percent (%) Body Weight) for Each Treatment Group.
Hide Description Values shown are observed change from Baseline to month 9. Measured by Magnetic resonance imaging (MRI). Spleen volume was normalized for percent (%) of body weight for each treatment arm. Spleen size relative to body weight=(Spleen volume [cc]/Body weight [kg])*100.
Time Frame Baseline to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Ten participants in each treatment group underwent splenectomy, and therefore, were excluded from the analysis.
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description:
Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: cm^3
-1.34  (0.424) -2.46  (0.966)
5.Secondary Outcome
Title Change From Baseline to Month 9 in Plasma Chitotriosidase for Each Treatment Group.
Hide Description Values shown are observed change from Baseline to Month 9. Units of measure is defined as nanomole per milliliter per hour.
Time Frame Baseline to Month 9.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Number of participants analyzed signifies participants evaluable for this outcome. Chitotriosidase levels were measured in 10 participants in the velaglucerase alfa group and 11 participants in the imiglucerase group.
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description:
Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Overall Number of Participants Analyzed 10 11
Mean (Standard Error)
Unit of Measure: nanomole/milliliter/hour (nmol/mL/h)
-34711.9  (6887.77) -35109.5  (7310.22)
6.Secondary Outcome
Title Change From Baseline to Month 9 in Plasma Chemokine (C-C Motif) Ligand 18 (CCL18) for Each Treatment Group.
Hide Description Values shown are observed change from Baseline to Month 9.
Time Frame Baseline to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description:
Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Overall Number of Participants Analyzed 17 17
Mean (Standard Error)
Unit of Measure: nanogram per milliliter (ng/mL)
-926.2  (113.29) -1153.4  (269.63)
7.Secondary Outcome
Title Number of Participants Who Developed Antibody for Each Treatment Group.
Hide Description Measure type is actual number of participants who developed antibodies to treatment; GA-GCB or imiglucerase. Antibody detection was based upon serum samples collected at various time points throughout the study. Serum samples were screened using an enzyme-linked immunosorbent assay (ELISA) and positive antibody confirmation was determined using a radioimmunoprecipitation assay (RIP); positive samples were also tested for enzyme neutralizing activity. Participant samples were compared to internal assay controls (positive/negative), positive samples were determined based upon individual assay criteria.
Time Frame Baseline to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population comprised of all randomized participants who received at least 1 full or partial dose of study drug.
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description:
Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Overall Number of Participants Analyzed 17 17
Measure Type: Number
Unit of Measure: participants
0 4
8.Secondary Outcome
Title Time to Response- Comparison of GA-GCB and Imiglucerase on the Earliest Time to Respond as Assessed Via Hemoglobin Concentration
Hide Description Time to response was defined as a ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline. Units (%) correlates to the percentage of participants who had a change of ≥ 1 g/dL improvement in hemoglobin levels relative to Baseline during their participation in the study.
Time Frame Response rate at Month 9 compared to Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description:
Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
Overall Number of Participants Analyzed 17 17
Measure Type: Number
Unit of Measure: Percentage of participants
92.9 100
Time Frame Adverse events (AE) monitored from time informed consent/assent obtained through 30 days after the last infusion. For participants who completed this study and elected to enroll in the long-term extension study, AEs were monitored through the Week 41.
Adverse Event Reporting Description AE may have been discovered via observation, examination, questioning or complaint by participants.Unexpected laboratory values that became significantly out of range and determined to be clinically significant by the investigator could have been reported as AEs.Other AE were determined to be possibly/probably related to GA-GCB by the investigator.
 
Arm/Group Title Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Hide Arm/Group Description Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks. Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
All-Cause Mortality
Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/17 (17.65%)      0/17 (0.00%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1 [1]  1/17 (5.88%)  2 0/17 (0.00%)  0
Nervous system disorders     
Convulsions  1 [1]  1/17 (5.88%)  1 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1 [2]  1/17 (5.88%)  1 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
[1]
Not related
[2]
Probably related
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gene-Activated Human Glucocerebrosidase (GA-GCB) Imiglucerase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/17 (94.12%)      16/17 (94.12%)    
Blood and lymphatic system disorders     
Thrombocythaemia  1  1/17 (5.88%)  1 1/17 (5.88%)  1
Spontaneous haematoma  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Thrombocytopenia  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Cardiac disorders     
Sinus bradycardia  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Sinus tachycardia  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Eye disorders     
Dry eye  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Conjunctivitis  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Gastrointestinal disorders     
Vomiting  1  1/17 (5.88%)  2 2/17 (11.76%)  2
Nausea  1  1/17 (5.88%)  3 0/17 (0.00%)  0
Abdominal pain  1  1/17 (5.88%)  2 2/17 (11.76%)  3
Abdominal discomfort  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Aphthous stomatitis  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Abdominal pain upper  1  1/17 (5.88%)  1 3/17 (17.65%)  4
Diarrhoea  1  3/17 (17.65%)  4 1/17 (5.88%)  1
Constipation  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Food poisoning  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Gastrointestinal disorder  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Gingival bleeding  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Tooth loss  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Odynophagia  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Toothache  1  1/17 (5.88%)  1 0/17 (0.00%)  0
General disorders     
Pyrexia  1  4/17 (23.53%)  4 2/17 (11.76%)  3
Oedema peripheral  1  3/17 (17.65%)  3 0/17 (0.00%)  0
Chills  1  0/17 (0.00%)  0 1/17 (5.88%)  2
Face oedema  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Feeling abnormal  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Feeling cold  1  0/17 (0.00%)  0 1/17 (5.88%)  3
Feeling hot  1  0/17 (0.00%)  0 1/17 (5.88%)  2
Asthenia  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Axillary pain  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Fatigue  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Inflammatory pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Hunger  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Injection site haemorrhage  1  1/17 (5.88%)  1 1/17 (5.88%)  1
Influenza like illness  1  0/17 (0.00%)  0 2/17 (11.76%)  4
Pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Immune system disorders     
Hypersensitivity  1  2/17 (11.76%)  2 0/17 (0.00%)  0
Food allergy  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Infections and infestations     
Bronchitis  1  1/17 (5.88%)  1 2/17 (11.76%)  2
Bronchitis acute  1  1/17 (5.88%)  2 1/17 (5.88%)  1
Cystitis  1  2/17 (11.76%)  2 1/17 (5.88%)  1
Cervicitis  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Ear infection  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Gastroenteritis  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Helminthic infection  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Infection parasitic  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Herpes simplex  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Influenza  1  3/17 (17.65%)  4 4/17 (23.53%)  6
Nasopharyngitis  1  3/17 (17.65%)  3 3/17 (17.65%)  3
Otitis externa  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Paronychia  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Pulpitis dental  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Respiratory tract infection  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Rhinitis  1  3/17 (17.65%)  3 1/17 (5.88%)  1
Skin bacterial infection  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Sinusitis  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Staphylococcal infection  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Tinea versicolour  1  2/17 (11.76%)  2 0/17 (0.00%)  0
Tonsillitis  1  1/17 (5.88%)  2 0/17 (0.00%)  0
Upper respiratory tract infection  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Tooth infection  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Urinary tract infection  1  2/17 (11.76%)  2 0/17 (0.00%)  0
Viral infection  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Injury, poisoning and procedural complications     
Post-Traumatic pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Injury  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Tongue injury  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Blood pressure systolic increased  1  0/17 (0.00%)  0 1/17 (5.88%)  2
Oxygen saturation decreased  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Prothrombin time prolonged  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Blood potassium increased  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Electrocardiogram abnormal  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Laboratory test abnormal  1  1/17 (5.88%)  1 1/17 (5.88%)  1
Serum ferritin increased  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/17 (23.53%)  11 3/17 (17.65%)  21
Pain in extremity  1  1/17 (5.88%)  1 1/17 (5.88%)  3
Arthritis  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Arthropathy  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Back pain  1  2/17 (11.76%)  2 2/17 (11.76%)  3
Bone pain  1  2/17 (11.76%)  4 3/17 (17.65%)  3
Myalgia  1  2/17 (11.76%)  2 1/17 (5.88%)  1
Muscle spasms  1  1/17 (5.88%)  1 2/17 (11.76%)  2
Neck pain  1  2/17 (11.76%)  2 1/17 (5.88%)  1
Shoulder pain  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders     
Headache  1  3/17 (17.65%)  7 3/17 (17.65%)  6
Paraesthesia  1  2/17 (11.76%)  2 1/17 (5.88%)  1
Convulsion  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Carpal tunnel syndrome  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Dizziness  1  1/17 (5.88%)  1 2/17 (11.76%)  3
Hemiparesis  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Migraine  1  0/17 (0.00%)  0 1/17 (5.88%)  2
Tremor  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Psychiatric disorders     
Insomnia  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Renal and urinary disorders     
Dysuria  1  1/17 (5.88%)  1 1/17 (5.88%)  1
Reproductive system and breast disorders     
Pelvic Pain  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Vaginal discharge  1  0/17 (0.00%)  0 1/17 (5.88%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/17 (11.76%)  2 2/17 (11.76%)  2
Dyspnoea  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Epistaxis  1  2/17 (11.76%)  2 2/17 (11.76%)  7
Pharyngolaryngeal pain  1  1/17 (5.88%)  1 1/17 (5.88%)  1
Respiratory disorder  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Stridor  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Rhinorrhoea  1  1/17 (5.88%)  1 1/17 (5.88%)  1
Skin and subcutaneous tissue disorders     
Urticaria  1  2/17 (11.76%)  2 1/17 (5.88%)  2
Pruritus  1  2/17 (11.76%)  3 0/17 (0.00%)  0
Dermatitis allergic  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Lichen planus  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Rash  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Alopecia  1  1/17 (5.88%)  1 1/17 (5.88%)  1
Rash pruritic  1  0/17 (0.00%)  0 1/17 (5.88%)  1
Swelling face  1  1/17 (5.88%)  2 0/17 (0.00%)  0
Vascular disorders     
Hypotension  1  1/17 (5.88%)  1 1/17 (5.88%)  1
Flushing  1  0/17 (0.00%)  0 1/17 (5.88%)  2
Hypertension  1  1/17 (5.88%)  1 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
Participants aged 2-4 years: 4 participants (23.5%) in imiglucerase group and 0 participants in GA-GCB 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.
Shire’s agreements with investigators vary. All agreements provide Shire the right to embargo communications regarding trial results prior to public release for a period ≤180 days from the time submitted to Shire for review. Shire does not prohibit publication, but can require the removal of confidential information (excluding trial results) and can request postponement of a single-center publication until after disclosure of the trial’s multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tiffany Crump, Medical Communications Manager
Organization: Shire HGT
Phone: 484-595-8850
EMail: tcrump@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00553631    
Other Study ID Numbers: HGT-GCB-039
2007-002840-21 ( EudraCT Number )
First Submitted: November 1, 2007
First Posted: November 4, 2007
Results First Submitted: July 12, 2010
Results First Posted: January 4, 2011
Last Update Posted: August 7, 2015