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A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B

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: NCT01496274
Recruitment Status : Completed
First Posted : December 21, 2011
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hemophilia B
Intervention Biological: rIX-FP
Enrollment 63
Recruitment Details Subjects were enrolled from 30 sites in 10 countries.
Pre-assignment Details A total of 69 subjects provided informed consent and were screened for study participation. Of these, 63 subjects were enrolled and treated with rIX-FP.
Arm/Group Title Prophylaxis On-demand
Hide Arm/Group Description

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Period Title: Overall Study
Started 40 23
Completed 37 18
Not Completed 3 5
Reason Not Completed
Protocol Violation             0             1
Adverse Event             1             1
Withdrawal by Subject             2             0
Lost to Follow-up             0             3
Arm/Group Title Prophylaxis On-demand Total
Hide Arm/Group Description

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration

Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration

Total of all reporting groups
Overall Number of Baseline Participants 40 23 63
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Safety Population
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 23 participants 63 participants
0 to 11 years 0 0 0
12 to 17 years 7 0 7
18 to 64 years 33 23 56
65 years and over 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 23 participants 63 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
40
 100.0%
23
 100.0%
63
 100.0%
1.Primary Outcome
Title Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized)
Hide Description Subjects in the on-demand arm received on-demand dosing with rIX-FP for up to 26 weeks (on-demand regimen), and then received weekly prophylaxis with rIX-FP for the remainder of the study (prophylaxis regimen). The effectiveness of prophylaxis in comparison to on-demand therapy was investigated by comparing the same subject’s annualized spontaneous bleeding rate (AsBR) during the on-demand regimen and during the prophylaxis regimen.
Time Frame Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes only the participants assigned to the on-demand arm who received at least 1 dose of rIX-FP in the on-demand regimen and at least 1 dose of rIX-FP in the prophylaxis regimen.
Arm/Group Title On-demand Arm, On-demand Regimen On-demand Arm, Prophylaxis Regimen
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Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
Overall Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: bleeds/year/subject
15.43
(7.98 to 17.96)
0.00
(0.00 to 0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection On-demand Arm, On-demand Regimen, On-demand Arm, Prophylaxis Regimen
Comments A test of null hypothesis that the ratio of AsBR (prophylaxis regimen/on-demand regimen) was ≥ 0.50 was conducted at the 1-sided 0.025 level. Matched pairs design with 19 subjects and 2 observations per subject.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P value is based on a Wilcoxon signed-rank test of H0: AsBR ratio (prophylaxis regimen/on-demand regimen) ≥ 0.50. The ratio was based on the original scale.
Method Wilcoxon signed-rank test
Comments [Not Specified]
2.Primary Outcome
Title Number of Subjects Developing Inhibitors Against Factor IX (FIX)
Hide Description The number of participants developing inhibitors against factor IX (FIX) along with the 95% Clopper-Pearson confidence interval, are summarized for subjects with 50 or more exposure days (EDs) to rIX-FP, and for all participants in the study.
Time Frame Up to 27.7 months (maximum)
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Safety Population
Arm/Group Title Safety Population
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The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
Participants with >=50 EDs to rIX-FP (n = 49)
0
(0.0 to 7.3)
All participants (n = 63)
0
(0.0 to 5.7)
3.Secondary Outcome
Title The Frequency of Related Adverse Events
Hide Description The percentage of participants experiencing treatment-related adverse-events (TEAEs).
Time Frame For the duration of the study; median 20.27 months.
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Safety Population
Arm/Group Title Prophylaxis On-demand Safety Population
Hide Arm/Group Description:

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
Overall Number of Participants Analyzed 40 23 63
Measure Type: Number
Unit of Measure: Percentage of participants
Related TEAE 10.0 4.3 7.9
Not related TEAE 87.5 78.3 84.1
4.Secondary Outcome
Title Number of Subjects Developing Antibodies Against rIX-FP
Hide Description [Not Specified]
Time Frame For the duration of the study; median 20.27 months.
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Safety Population
Arm/Group Title Safety Population
Hide Arm/Group Description:
The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: participants
0
5.Secondary Outcome
Title Proportion of Bleeding Episodes Requiring One or ≤ Two Injections of rIX-FP to Achieve Hemostasis
Hide Description Number of injections required to achieve hemostasis expressed as a percentage of the bleeding episodes requiring treatment.
Time Frame For the duration of the study; median 20.27 months.
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Hide Analysis Population Description
Efficacy Population
Arm/Group Title Prophylaxis On-demand Arm, On-demand Regimen On-demand Arm, Prophylaxis Regimen
Hide Arm/Group Description:

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
Overall Number of Participants Analyzed 40 23 19
Overall Number of Units Analyzed
Type of Units Analyzed: Bleeding episodes requiring treatment
101 220 37
Measure Type: Number
Unit of Measure: percentage of bleeding episodes treated
1 injection 92.1 94.5 91.9
1 or 2 injections 100.0 98.6 94.6
6.Secondary Outcome
Title Investigator’s Overall Clinical Assessment of Hemostatic Efficacy for Treatment of Bleeding Episodes, Based on a Four Point Ordinal Scales (Excellent, Good, Moderate, Poor/No Response)
Hide Description Number of bleeding episodes requiring treatment that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator’s clinical assessment of hemostatic efficacy, expressed as a percentage of the bleeding episodes requiring treatment.
Time Frame For the duration of the study; median 20.27 months
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Hide Analysis Population Description
Efficacy Population
Arm/Group Title Prophylaxis On-demand
Hide Arm/Group Description:

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Overall Number of Participants Analyzed 40 23
Overall Number of Units Analyzed
Type of Units Analyzed: Bleeding episodes requiring treatment
101 257
Measure Type: Number
Unit of Measure: percentage of bleeding episodes
Excellent 71.3 87.5
Good 20.8 7.4
Moderate 3.0 2.3
Poor/No response 0 0.4
Missing 5.0 2.3
7.Secondary Outcome
Title rIX-FP Consumed Per Month While Maintaining Assigned Prophylactic Treatment Interval During Routine Prophylaxis.
Hide Description Time frame: For Prophylaxis Arm 7-, 10- and 14-day regimens, median 269, 240 and 386 days respectively. For On-demand Arm, prophylaxis regimen, median 316 days.
Time Frame Median 269, 240, 386 and 316 days, respectively (see Description)
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Efficacy Population
Arm/Group Title On-demand Arm, Prophylaxis Regimen Prophylaxis Arm, 7-day Regimen Prophylaxis Arm, 10-day Regimen Prophylaxis Arm, 14-day Regimen
Hide Arm/Group Description:
Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
Subjects received prophylactic rIX-FP on a weekly basis.
Subjects received prophylactic rIX-FP every 10 days.
Subjects received prophylactic rIX-FP every 14 days.
Overall Number of Participants Analyzed 19 40 7 21
Mean (Standard Deviation)
Unit of Measure: IU/kg/month
191.69  (36.33) 202.68  (47.92) 201.50  (42.56) 157.44  (16.34)
8.Secondary Outcome
Title Incremental Recovery of rIX-FP
Hide Description Pharmacokinetic (PK) data are presented for a single 50 IU/kg dose of rIX-FP.
Time Frame 336 hours
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Hide Analysis Population Description
The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.
Arm/Group Title Prophylaxis On-demand
Hide Arm/Group Description:

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Overall Number of Participants Analyzed 27 18
Mean (Standard Deviation)
Unit of Measure: (IU/dL)/(IU/kg)
1.29  (0.33) 1.24  (0.25)
9.Secondary Outcome
Title Half-life (t1/2) of a Single Dose of rIX-FP
Hide Description PK data are presented for a single 50 IU/kg dose of rIX-FP.
Time Frame 336 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.
Arm/Group Title Prophylaxis On-demand
Hide Arm/Group Description:

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Episodic treatment for bleeding episodes up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Overall Number of Participants Analyzed 26 17
Mean (Standard Deviation)
Unit of Measure: hour
104.77  (22.73) 96.88  (20.94)
10.Secondary Outcome
Title Area Under the Curve (AUC)
Hide Description AUC to the last sample with quantifiable drug concentration (AUClast) of a single dose of rIX-FP. PK data are presented for a single 50 IU/kg dose of rIX-FP.
Time Frame 336 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.
Arm/Group Title Prophylaxis On-demand
Hide Arm/Group Description:

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Overall Number of Participants Analyzed 27 18
Mean (Standard Deviation)
Unit of Measure: IU*hr/dL
6534.15  (1856.96) 5963.30  (1893.00)
11.Secondary Outcome
Title Clearance of a Single Dose of rIX-FP
Hide Description PK data are presented for a single 50 IU/kg dose of rIX-FP.
Time Frame 336 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.
Arm/Group Title Prophylaxis On-demand
Hide Arm/Group Description:

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Overall Number of Participants Analyzed 26 17
Mean (Standard Deviation)
Unit of Measure: mL/hr
50.19  (12.92) 59.00  (19.37)
12.Secondary Outcome
Title Investigator’s (or Surgeon’s) Overall Clinical Assessment of Hemostatic Efficacy for Surgical Prophylaxis, Based on a Four Point Ordinal Scale (Excellent, Good, Moderate, Poor/No Response)
Hide Description Number of surgical events treated prophylactically with rIX-FP that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator’s (surgeon’s) overall assessment of hemostatic efficacy for surgical prophylaxis.
Time Frame Up to 14 days after surgery
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Surgical Population
Arm/Group Title Surgical Population
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The Surgical population consisted of 3 subjects in the prophylaxis arm and 1 subject in the on demand arm who received at least 1 dose of rIX FP for a major or minor surgical procedure.
Overall Number of Participants Analyzed 4
Overall Number of Units Analyzed
Type of Units Analyzed: Events
6
Measure Type: Number
Unit of Measure: events
Excellent 6
Good 0
Moderate 0
Poor/No response 0
13.Secondary Outcome
Title Annualized Spontaneous Bleeding Events Compared Between 7 Day Prophylactic and Extended Regimens
Hide Description Median number of spontaneous bleeds per year per subject comparing 7-, 10- and 14- day prophylactic regimens.
Time Frame During treatment, between median 240 and 386 days per subject.
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Efficacy Population
Arm/Group Title Prophylaxis Arm, 7-day Regimen Prophylaxis Arm, 10-day Regimen Prophylaxis Arm, 14-day Regimen
Hide Arm/Group Description:
Subjects received prophylactic rIX-FP on a weekly basis.
Subjects received prophylactic rIX-FP every 10 days.
Subjects received prophylactic rIX-FP every 14 days.
Overall Number of Participants Analyzed 38 7 21
Median (Inter-Quartile Range)
Unit of Measure: bleeds/year/subject
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 1.00)
Time Frame For the duration of the study, up to 27.7 months.
Adverse Event Reporting Description

The Safety analysis population consisted of subjects who received at least 1 dose of rIX-FP during the study. Adverse Event (AE) data are treatment-emergent data unless otherwise noted.

The total number of participants in the number affected by Other (non-serious) AEs, is the total number of participants experiencing at least one non-serious AE.

 
Arm/Group Title Prophylaxis On-demand
Hide Arm/Group Description

Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.

Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.

All-Cause Mortality
Prophylaxis On-demand
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prophylaxis On-demand
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      2/23 (8.70%)    
Musculoskeletal and connective tissue disorders     
SYNOVITIS  1  0/40 (0.00%)  0 1/23 (4.35%)  1
PAIN IN EXTREMITY  1 [1]  1/40 (2.50%)  1 0/23 (0.00%)  0
MUSCLE HAEMORRHAGE  1 [1]  1/40 (2.50%)  1 0/23 (0.00%)  0
Nervous system disorders     
ACQUIRED EPILEPTIC APHASIA  1  0/40 (0.00%)  0 1/23 (4.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
[1]
This serious adverse event was not treatment-emergent.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prophylaxis On-demand
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/40 (90.00%)      18/23 (78.26%)    
Gastrointestinal disorders     
DIARRHOEA  1  2/40 (5.00%)  2 3/23 (13.04%)  4
TOOTHACHE  1  4/40 (10.00%)  4 1/23 (4.35%)  1
Infections and infestations     
NASOPHARYNGITIS  1  10/40 (25.00%)  27 6/23 (26.09%)  11
INFLUENZA  1  4/40 (10.00%)  7 3/23 (13.04%)  3
UPPER RESPIRATORY TRACT INFECTION  1  5/40 (12.50%)  7 0/23 (0.00%)  0
BRONCHITIS  1  4/40 (10.00%)  4 1/23 (4.35%)  1
PHARYNGITIS  1  3/40 (7.50%)  3 2/23 (8.70%)  2
GASTROENTERITIS  1  3/40 (7.50%)  4 0/23 (0.00%)  0
ACUTE TONSILLITIS  1  0/40 (0.00%)  0 2/23 (8.70%)  2
Injury, poisoning and procedural complications     
LIMB INJURY  1  5/40 (12.50%)  5 1/23 (4.35%)  1
CONTUSION  1  3/40 (7.50%)  5 1/23 (4.35%)  3
LACERATION  1  1/40 (2.50%)  1 2/23 (8.70%)  2
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  9/40 (22.50%)  19 0/23 (0.00%)  0
BACK PAIN  1  4/40 (10.00%)  5 2/23 (8.70%)  3
SYNOVITIS  1  3/40 (7.50%)  6 0/23 (0.00%)  0
PAIN IN EXTREMITY  1  3/40 (7.50%)  4 0/23 (0.00%)  0
JOINT SWELLING  1  3/40 (7.50%)  3 0/23 (0.00%)  0
TENDONITIS  1  3/40 (7.50%)  3 0/23 (0.00%)  0
Nervous system disorders     
HEADACHE  1  11/40 (27.50%)  26 4/23 (17.39%)  8
DIZZINESS  1  4/40 (10.00%)  5 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
COUGH  1  3/40 (7.50%)  3 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders     
ACNE  1  3/40 (7.50%)  3 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
Phone: Use email contact
EMail: clinicaltrials@cslbehring.com
Layout table for additonal information
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01496274     History of Changes
Other Study ID Numbers: CSL654_3001
2011-002415-28 ( EudraCT Number )
First Submitted: December 19, 2011
First Posted: December 21, 2011
Results First Submitted: April 3, 2016
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016