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PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A

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: NCT02492984
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hemophilia A
Intervention Drug: Intravenous infusions of Xyntha
Enrollment 85
Recruitment Details  
Pre-assignment Details As there were 2 participants who rolled over from the surgical prophylaxis group to the on-demand group should be counted once in total column, the total number of baseline participants was 85.
Arm/Group Title On-Demand Group Surgical Prophylaxis Group
Hide Arm/Group Description Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs). Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
Period Title: Overall Study
Started 73 14
Completed 70 14
Not Completed 3 0
Reason Not Completed
Adverse Event             1             0
Protocol Violation             1             0
Withdrawal by Subject             1             0
Arm/Group Title On-Demand Group Surgical Prophylaxis Group Total
Hide Arm/Group Description Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs). Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions. Total of all reporting groups
Overall Number of Baseline Participants 73 14 87
Hide Baseline Analysis Population Description
As there were 2 participants who rolled over from the surgical prophylaxis group to the on-demand group should be counted once in total column, the total number of baseline participants was 85.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 14 participants 87 participants
7.2  (4.8) 21.0  (15.0) 9.5  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 14 participants 87 participants
Female
1
   1.4%
0
   0.0%
1
   1.1%
Male
72
  98.6%
14
 100.0%
86
  98.9%
1.Primary Outcome
Title Percentage of Participants With Factor VIII (FVIII) Inhibitors
Hide Description Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study).
Time Frame From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.
Arm/Group Title On-Demand Group Surgical Prophylaxis Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
Overall Number of Participants Analyzed 73 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.22
(3.08 to 17.04)
7.14
(0.18 to 33.87)
2.Secondary Outcome
Title Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.
Time Frame From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.
Arm/Group Title On-Demand Group Surgical Prophylaxis Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
Overall Number of Participants Analyzed 73 14
Measure Type: Number
Unit of Measure: participants
Participants with AEs 65 10
Participants with SAEs 7 1
3.Secondary Outcome
Title Response Assessment of On-Demand Treatment of Bleeds
Hide Description The proportion of infusions (initial and subsequent for a bleed) in each response category (excellent, good, moderate, no response) was reported. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. No Response: No improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsens.
Time Frame From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the "surgical prophylaxis group".
Arm/Group Title On-Demand Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
Overall Number of Participants Analyzed 73
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
2568
Measure Type: Number
Unit of Measure: percentage of infusions
Excellent 46.9
Good 40.0
Moderate 12.7
No Response 0.3
Data Not Recorded 0.1
4.Secondary Outcome
Title Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment
Hide Description The number of Xyntha infusions administered to treat a bleed was determined. This was calculated by adding the on-demand initial treatment and any on-demand follow-up infusions for the same bleed (same bleed start date/time).
Time Frame From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the "surgical prophylaxis group".
Arm/Group Title On-Demand Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: infusions
1.6  (0.94)
5.Secondary Outcome
Title Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group
Time Frame From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the "surgical prophylaxis group".
Arm/Group Title On-Demand Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
Overall Number of Participants Analyzed 73
Overall Number of Units Analyzed
Type of Units Analyzed: Bleeds
1610
Measure Type: Number
Unit of Measure: percentage of bleeds
1 Infusion 63.0
2 Infusions 21.9
3 Infusions 8.6
4 Infusions 6.0
>4 Infusions 0.5
6.Secondary Outcome
Title Hemostatic Efficacy for Surgical Prophylaxis Treatment
Hide Description Assessment of hemostatic efficacy was determined by the investigator and/or surgeon using the 4 point Surgical Hemostasis Efficacy Rating Scale. Excellent: Achieved hemostasis comparable to that expected after similar surgery in a non hemophilic participant. Good: Prolonged time to hemostasis, with somewhat increased bleeding compared to that expected after similar surgery in a non hemophilic participant. Moderate: Obviously delayed hemostasis, but manageable with additional infusions. No Response: No hemostatic response. The percentage of observations in each hemostatic efficacy response category (excellent, good, moderate, none) was reported.
Time Frame From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the "on-demand group".
Arm/Group Title Surgical Prophylaxis Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage of observations
Day of Surgery: Excellent 71.4
Day of Surgery: Good 28.6
Day of Surgery: Moderate 0
Day of Surgery: None 0
Post-Operative: Excellent 75.5
Post-Operative: Good 24.5
Post-Operative: Moderate 0
Post-Operative: None 0
7.Secondary Outcome
Title Actual Estimated Blood Loss for Surgical Prophylaxis Treatment
Hide Description Number of participants with blood loss in each category (Abnormal, Normal, and Absence). Blood loss during the intraoperative and the postoperative period were assessed by investigator or surgeon, which were rated as Abnormal, Normal, and Absence. Abnormal blood loss meant the blood loss was higher over the expectation for the non hemophilic participant.
Time Frame From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the "on-demand group". Number of participants analyzed signifies participants evaluable for this outcome measure.
Arm/Group Title Surgical Prophylaxis Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: partcipants
Abnormal 0
Normal 13
Absence 0
8.Secondary Outcome
Title Number of Participants With Transfusion Requirement for Surgical Prophylaxis Treatment
Hide Description Number of participants with transfusion requirement for surgical prophylaxis treatment. Transfusion requirements during the intraoperative and the postoperative period were assessed by investigator or surgeon. The number of units and types of blood products transfused were recorded if applicable.
Time Frame From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the "on-demand group".
Arm/Group Title Surgical Prophylaxis Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
2
9.Secondary Outcome
Title Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment
Hide Description The total amount (IU) infused for each Xyntha infusion recorded in the study drug infusion log case report form (CRF) was summed to calculate the total factor VIII consumption for each participant. The average infusion dose for each participant was calculated as his total factor VIII consumption (in IU) divided by the number of infusions administered. The total factor VIII consumption, divided by number of infusions, was summarized similarly to average infusion dose (IU).
Time Frame On-Demand Group: Day 1 up to 6 months or 50 EDs whichever occurred first. Surgical Prophylaxis Group: Day of surgery to postoperative period. The duration of postoperative period is specified in previous endpoints.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of Xyntha during the study
Arm/Group Title On-Demand Group Surgical Prophylaxis Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
Overall Number of Participants Analyzed 73 14
Mean (Standard Deviation)
Unit of Measure: International Unit (IU)
Average Infusion Dose 674.68  (357.613) 1245.07  (494.268)
Total FVIII Consumption per Participant 25211.0  (22035.35) 39860.7  (27546.15)
10.Secondary Outcome
Title Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting
Hide Description LETE occurred in the on-demand setting if 2 successive “No Response” ratings were recorded after 2 successive Xyntha drug infusions, respectively.The infusions must have been administered within 24 hours (less than or equal to 24 hours) of each other for treatment of the same bleeding event in the absence of confounding factors (prespecified). Therefore, LETE in the on-demand setting was based on the response to treatment of a bleeding episode (including those occurring during the surgical prophylaxis period). Note that on-demand treatments administered during the surgical prophylaxis period were also to be included.
Time Frame From Day 1 up to participants had received treatment for 6 months or participants had achieved 50 EDs whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.
Arm/Group Title On-Demand Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
Overall Number of Participants Analyzed 73
Overall Number of Units Analyzed
Type of Units Analyzed: Bleeding episodes
1610
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of bleeding episodes
0.06
(0.00 to 0.35)
11.Secondary Outcome
Title Number of Confirmed LETE in the Low Recovery Setting
Hide Description LETE could also be lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors. The only confounding factors for low recovery were: known presence or subsequent identification of a FVIII inhibitor; known compromised Xyntha; faulty administration of Xyntha, including inadequate dosing.
Time Frame From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.
Arm/Group Title On-Demand Group Surgical Prophylaxis Group
Hide Arm/Group Description:
Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
Overall Number of Participants Analyzed 73 14
Measure Type: Number
Unit of Measure: LETE bleeds
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title On-Demand Group Surgical Prophylaxis Group Total
Hide Arm/Group Description Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs). Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions. Treatment Group Description TBD
All-Cause Mortality
On-Demand Group Surgical Prophylaxis Group Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
On-Demand Group Surgical Prophylaxis Group Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/73 (9.59%)   1/14 (7.14%)   8/85 (9.41%) 
Blood and lymphatic system disorders       
Factor VIII inhibition * 1  6/73 (8.22%)  1/14 (7.14%)  7/85 (8.24%) 
Injury, poisoning and procedural complications       
Gingival injury * 1  1/73 (1.37%)  0/14 (0.00%)  1/85 (1.18%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
On-Demand Group Surgical Prophylaxis Group Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/73 (84.93%)   9/14 (64.29%)   70/85 (82.35%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/73 (0.00%)  2/14 (14.29%)  2/85 (2.35%) 
Gastrointestinal disorders       
Abdominal distension * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Constipation * 1  1/73 (1.37%)  1/14 (7.14%)  2/85 (2.35%) 
Nausea * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Vomiting * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
General disorders       
Local swelling * 1  4/73 (5.48%)  0/14 (0.00%)  4/85 (4.71%) 
Peripheral swelling * 1  15/73 (20.55%)  0/14 (0.00%)  15/85 (17.65%) 
Pyrexia * 1  15/73 (20.55%)  2/14 (14.29%)  17/85 (20.00%) 
Hepatobiliary disorders       
Hepatic function abnormal * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Infections and infestations       
Nasopharyngitis * 1  18/73 (24.66%)  0/14 (0.00%)  18/85 (21.18%) 
Tonsillitis * 1  6/73 (8.22%)  1/14 (7.14%)  7/85 (8.24%) 
Upper respiratory tract infection * 1  7/73 (9.59%)  0/14 (0.00%)  7/85 (8.24%) 
Injury, poisoning and procedural complications       
Contusion * 1  6/73 (8.22%)  0/14 (0.00%)  6/85 (7.06%) 
Fall * 1  9/73 (12.33%)  0/14 (0.00%)  9/85 (10.59%) 
Incision site oedema * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Incision site pain * 1  0/73 (0.00%)  4/14 (28.57%)  4/85 (4.71%) 
Joint injury * 1  5/73 (6.85%)  0/14 (0.00%)  5/85 (5.88%) 
Ligament sprain * 1  4/73 (5.48%)  0/14 (0.00%)  4/85 (4.71%) 
Procedural complication * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  24/73 (32.88%)  2/14 (14.29%)  26/85 (30.59%) 
Arthropathy * 1  4/73 (5.48%)  0/14 (0.00%)  4/85 (4.71%) 
Haemarthrosis * 1  3/73 (4.11%)  1/14 (7.14%)  4/85 (4.71%) 
Joint range of motion decreased * 1  4/73 (5.48%)  0/14 (0.00%)  4/85 (4.71%) 
Joint swelling * 1  34/73 (46.58%)  3/14 (21.43%)  37/85 (43.53%) 
Muscle swelling * 1  11/73 (15.07%)  0/14 (0.00%)  11/85 (12.94%) 
Pain in extremity * 1  18/73 (24.66%)  0/14 (0.00%)  18/85 (21.18%) 
Nervous system disorders       
Hypoaesthesia * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Psychiatric disorders       
Insomnia * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Renal and urinary disorders       
Dysuria * 1  0/73 (0.00%)  2/14 (14.29%)  2/85 (2.35%) 
Reproductive system and breast disorders       
Penile oedema * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Penile pain * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  10/73 (13.70%)  0/14 (0.00%)  10/85 (11.76%) 
Skin and subcutaneous tissue disorders       
Ecchymosis * 1  9/73 (12.33%)  0/14 (0.00%)  9/85 (10.59%) 
Pruritus * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Rash * 1  0/73 (0.00%)  1/14 (7.14%)  1/85 (1.18%) 
Swelling face * 1  6/73 (8.22%)  0/14 (0.00%)  6/85 (7.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from completion/termination at all participating sties. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02492984     History of Changes
Other Study ID Numbers: B1831083
2015-005040-33 ( EudraCT Number )
First Submitted: March 19, 2015
First Posted: July 9, 2015
Results First Submitted: December 19, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017