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Trial record 9 of 11 for:    Aevi

TARGTEPO Treatment for Anemia in PD US Trial

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ClinicalTrials.gov Identifier: NCT02468414
Recruitment Status : Terminated (No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.)
First Posted : June 10, 2015
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Medgenics Medical Israel Ltd.
Information provided by (Responsible Party):
Aevi Genomic Medicine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Anemia of End Stage Renal Disease
Intervention: Biological: MDGN201 TARGTEPO

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A 18-25 IU/Kg/day
Group B 35-45 IU/Kg/day

Participant Flow:   Overall Study
    Group A   Group B
STARTED   3   0 
Successfully Screened   2   0 
Harvesting   1   0 
Implantation   1   0 
Safety Follow-up   0   0 
COMPLETED   0   0 
NOT COMPLETED   3   0 
Early Study Termination by Sponsor                1                0 
Poor in-vitro secreting TARGTs                1                0 
Screen Failure                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group A TARGTEPO 18-25 IU/kg/day
Group B TARGTEPO 35-45 IU/kg/day
Total Total of all reporting groups

Baseline Measures
   Group A   Group B   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   0   3 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%   0      0   0.0% 
Between 18 and 65 years      3 100.0%   0      3 100.0% 
>=65 years      0   0.0%   0      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  33.3%   0      1  33.3% 
Male      2  66.7%   0      2  66.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%   0      0   0.0% 
Asian      0   0.0%   0      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%   0      0   0.0% 
Black or African American      0   0.0%   0      0   0.0% 
White      3 100.0%   0      3 100.0% 
More than one race      0   0.0%   0      0   0.0% 
Unknown or Not Reported      0   0.0%   0      0   0.0% 


  Outcome Measures

1.  Primary:   Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum EPO Levels Above Baseline.   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Garry A. Neil, MD
Organization: Aevi Genomic Medicine
phone: 610-254-4208
e-mail: garry.neil@aevigenomics.com



Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT02468414     History of Changes
Other Study ID Numbers: MG-EP-RF-04
First Submitted: June 4, 2015
First Posted: June 10, 2015
Results First Submitted: June 8, 2017
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017