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A Long-term Study for the Outcome of Pompe 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02399748
Recruitment Status : Recruiting
First Posted : March 26, 2015
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date March 21, 2015
First Posted Date March 26, 2015
Last Update Posted Date July 18, 2017
Study Start Date April 2007
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2015)
all cause morbidities [ Time Frame: 10 years ]
Original Primary Outcome Measures
 (submitted: March 25, 2015)
all cause morbilities [ Time Frame: 10 years ]
Change History Complete list of historical versions of study NCT02399748 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Long-term Study for the Outcome of Pompe Disease
Official Title A Long-term Study for the Outcome of Pompe Disease
Brief Summary Prospectively follow patients with Pompe disease underwent enzyme replacement therapy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients of Pompe disease who under enzyme replacement therapy
Condition Pompe Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 25, 2015)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Confirm diagnosis with Pompe disease, is or is preparing receiving enzyme replacement therapy

Exclusion Criteria:

No

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Yin-Hsiu Chien +886223123456 ext 71937 chienyh@ntu.edu.tw
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02399748
Other Study ID Numbers 200703045R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yin-Hsiu Chien National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date July 2017