ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

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: NCT01947907
Recruitment Status : Completed
First Posted : September 23, 2013
Results First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ascendis Pharma A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Growth Hormone Deficiency (GHD)
Interventions Drug: ACP-001
Drug: Human Growth Hormone
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Hide Arm/Group Description

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

Period Title: Overall Study
Started 12 14 14 13
Completed 12 14 14 13
Not Completed 0 0 0 0
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone Total
Hide Arm/Group Description

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

Total of all reporting groups
Overall Number of Baseline Participants 12 14 14 13 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 14 participants 13 participants 53 participants
<=18 years
12
 100.0%
14
 100.0%
14
 100.0%
13
 100.0%
53
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 14 participants 14 participants 13 participants 53 participants
7.98  (2.889) 8.24  (2.13) 7.32  (2.784) 7.53  (2.483) 7.77  (2.57)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 14 participants 13 participants 53 participants
Female
3
  25.0%
4
  28.6%
5
  35.7%
3
  23.1%
15
  28.3%
Male
9
  75.0%
10
  71.4%
9
  64.3%
10
  76.9%
38
  71.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 14 participants 13 participants 53 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
12
 100.0%
14
 100.0%
14
 100.0%
13
 100.0%
53
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 14 participants 14 participants 13 participants 53 participants
Russian Federation 4 4 7 6 21
Romania 1 0 0 1 2
Hungary 0 0 1 0 1
Egypt 2 4 0 1 7
Ukraine 1 4 1 1 7
Belarus 2 2 2 1 7
Greece 1 0 2 0 3
Turkey 1 0 0 2 3
Poland 0 0 1 0 1
Bulgaria 0 0 0 1 1
Baseline IGF-1 SDS (standard deviation score)  
Mean (Standard Deviation)
Unit of measure:  Standard Deviation Score
Number Analyzed 12 participants 14 participants 14 participants 13 participants 53 participants
-2.034  (0.7429) -2.017  (0.7713) -2.19  (0.7169) -2.502  (0.896) -2.19  (0.782)
Baseline Height SDS  
Mean (Standard Deviation)
Unit of measure:  Standard Deviation Score
Number Analyzed 12 participants 14 participants 14 participants 13 participants 53 participants
-3.05  (1.127) -2.75  (0.383) -3.17  (1.04) -3.27  (1.077) -3.06  (0.905)
Screening Peak GH Values  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 12 participants 14 participants 14 participants 13 participants 53 participants
5.09  (3.169) 5.16  (2.598) 4.44  (2.770) 5.15  (3.068) 4.95  (2.829)
1.Primary Outcome
Title Incidence of Anti-hGH Binding Antibody Formation
Time Frame Visit 2 - Visit 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set includes all patients who receive at least one dose of planned study medication
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

Overall Number of Participants Analyzed 12 14 14 13
Measure Type: Number
Unit of Measure: participants
1 0 0 0
2.Primary Outcome
Title Incidence of Anti-hGH Neutralizing Antibody Formation
Time Frame Visit 2 - Visit 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

Overall Number of Participants Analyzed 12 14 14 13
Measure Type: Number
Unit of Measure: participants
0 0 0 0
3.Primary Outcome
Title Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)
Hide Description Assessment of local tolerability was performed by examining injection sites (by the investigator during study visits) and on the basis of anamnestic data and records in the Patient Diary. Assessments included pain, redness, bruising, swelling, and itching. Every subject was counted only once within each symptom category.
Time Frame Start of study treatment through Visit 5 (Week 27)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

Overall Number of Participants Analyzed 12 14 14 13
Measure Type: Number
Unit of Measure: Number of subjects with any symptom
7 6 6 6
4.Primary Outcome
Title Cmax of hGH
Hide Description

As part of the following endpoint:

PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the pharmacokinetic (PK) profile of hGH from the daily rhGH groups during visit 1 and 3.

Uncorrected Cmax (maximum value of concentration) values at Visit 3 (Week 13)

Time Frame 0 hours to 168 hours at Visit 3 (Week 13)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

Overall Number of Participants Analyzed 12 14 14 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
12.558  (8.678) 13.418  (9.428) 31.8  (17.499) 16.612  (12.777)
5.Primary Outcome
Title AUC0-168h of hGH
Hide Description

As part of the following endpoint:

PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the PK profile of hGH from the daily rhGH group during Visit 1 and Visit 3

Uncorrected AUC0-168h (area under the curve from 0h to 168h) values at Visit 3 (Week 13)

Time Frame 0 hours to 168 hours at Visit 3 (Week 13)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

Overall Number of Participants Analyzed 12 14 14 13
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
696.34  (410.096) 787.41  (483.169) 2167.43  (1064.729) 556.88  (412.618)
6.Primary Outcome
Title E-Trough of IGF-1
Hide Description

As part of the following endpoint:

PD profile of serum IGF-1 during Visit 1 and Visit 3 compared between the ACP-001 dose groups and to the daily rhGH group

Uncorrected E-Trough (the pre-dose efficacy response) values at Week 13

Time Frame 0 hours to 168 hours at Visit 3 (Week 13)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Overall Number of Participants Analyzed 12 14 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
97.17  (50.53) 156  (76.235) 167.83  (74.01)
7.Primary Outcome
Title Emax of IGF-1
Hide Description

As part of the following endpoint:

PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the daily rhGH group

Time Frame 0 hours to 168 hours at Visit 3 (Week 13)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Overall Number of Participants Analyzed 12 14 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
209.5  (120.189) 276  (126.632) 289.92  (129.469)
8.Primary Outcome
Title AUEC0-168h of IGF-1
Hide Description

As part of the following endpoint:

PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the rhGH group.

Uncorrected AUEC0-168 (area under the efficacy curve from 0h-168h) values at Week 13

Time Frame 0 hours to 168 hours at Visit 3 (Week 13)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Overall Number of Participants Analyzed 12 14 14
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
28526.19  (15756.44) 35591.94  (17068.59) 36066.01  (17379.44)
9.Secondary Outcome
Title Annualized Height Velocity
Hide Description Annualized HV during treatment with ACP-001 or daily rhGH at the end of 6 months, for each ACP-001 dose group and for the daily rhGH dose group
Time Frame Baseline to 6 months (Visit 5)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Hide Arm/Group Description:

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

Overall Number of Participants Analyzed 12 14 14 13
Mean (Standard Deviation)
Unit of Measure: cm/year
11.93  (4.066) 12.89  (3.464) 13.85  (4.009) 11.64  (3.592)
Time Frame From start of the study treatment and continues until the end of the patient's participation in the study (until 4 weeks after stop of patient's study participation for serious adverse events)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Hide Arm/Group Description

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once weekly subcutaneous injection of ACP-001

ACP-001: Once weekly subcutaneous injection

Once daily subcutaneous injection of human Growth Hormone (rhGH)

Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone

All-Cause Mortality
ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/14 (0.00%)      0/14 (0.00%)      0/13 (0.00%)    
Gastrointestinal disorders         
Inguinal hernia  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACP-001, Dose-level 1 ACP-001, Dose-level 2 ACP-001, Dose-level 3 Human Growth Hormone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/12 (58.33%)      6/14 (42.86%)      8/14 (57.14%)      8/13 (61.54%)    
Blood and lymphatic system disorders         
Anemia  1  0/12 (0.00%)  0 2/14 (14.29%)  2 1/14 (7.14%)  1 0/13 (0.00%)  0
Iron deficiency anemia  1  0/12 (0.00%)  0 0/14 (0.00%)  0 2/14 (14.29%)  2 1/13 (7.69%)  1
Congenital, familial and genetic disorders         
Thalassemia beta  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Ear and labyrinth disorders         
Ear pain  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
Middle ear inflammation  1  0/12 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
Endocrine disorders         
Hypothyroidism  1  0/12 (0.00%)  0 1/14 (7.14%)  1 1/14 (7.14%)  1 1/13 (7.69%)  1
Secondary hypothyroidism  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0
Eye disorders         
Strabismus  1  0/12 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders         
Anal pruritis  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Diarrhea  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Inguinal hernia  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0
Nausea  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0
Vomiting  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
General disorders         
Fatigue  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Hyperthermia  1  1/12 (8.33%)  2 0/14 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0
Pyrexia  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 3/13 (23.08%)  3
Immune system disorders         
Food allergy  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Infections and infestations         
Bronchitis  1  0/12 (0.00%)  0 1/14 (7.14%)  1 2/14 (14.29%)  2 1/13 (7.69%)  1
Nasopharyngitis  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
Respiratory tract infection  1  1/12 (8.33%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Rhinitis  1  1/12 (8.33%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Tonsilitis  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Tooth abcess  1  0/12 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 1/13 (7.69%)  1
Tracheitis  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Varicella  1  0/12 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Injury, poisoning and procedural complications         
Heat exhaustion  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0
Open wound  1  0/12 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0
Procedural dizziness  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0
Investigations         
Blood triglycerides  1  0/12 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0
Metabolism and nutrition disorders         
Decreased appetite  1  1/12 (8.33%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0 0/13 (0.00%)  0
Nervous system disorders         
Headache  1  2/12 (16.67%)  2 0/14 (0.00%)  0 1/14 (7.14%)  1 1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  0/12 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
Oropharyngeal pain  1  0/12 (0.00%)  0 0/14 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: VP Clinical Development
Organization: Ascendis Pharma A/S
Phone: +49 172 155 2596
Responsible Party: Ascendis Pharma A/S
ClinicalTrials.gov Identifier: NCT01947907     History of Changes
Other Study ID Numbers: ACP-001_CT-004
First Submitted: June 3, 2013
First Posted: September 23, 2013
Results First Submitted: October 3, 2016
Results First Posted: January 19, 2017
Last Update Posted: January 19, 2017