UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050880 |
|---|---|
| Receipt number | R000057795 |
| Scientific Title | Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES): A multi country, non-interventional prospective cohort study among patients with human growth hormone (hGH) treatments under routine clinical care (PROGRES) |
| Date of disclosure of the study information | 2023/04/19 |
| Last modified on | 2023/10/30 14:16:31 |
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Basic information
Public title
A multi country, non-interventional prospective cohort study among patients with human growth hormone (hGH) treatments under routine clinical care
Acronym
PROGRES
Scientific Title
Pfizer Registry of Outcomes in Growth hormone RESearch (PROGRES): A multi country, non-interventional prospective cohort study among patients with human growth hormone (hGH) treatments under routine clinical care (PROGRES)
Scientific Title:Acronym
PROGRES
Region
| Japan | Asia(except Japan) | North America |
| Australia | Europe |
Condition
Condition
Growth hormone deficiency
Classification by specialty
| Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this multi-country, non interventional, prospective cohort study among patients treated according to routine clinical practice, will be to assess the long term safety and effectiveness of Genotropin, other daily human growth hormone (hGH) treatments, and Ngenla, a long-acting hGH, once granted marketing authorization and is commercially available, all of which is at the discretion of the treating physician according to routine clinical care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate incidence rates (IRs) of safety events of interest among patients on Genotropin, other daily hGH treatments, and Ngenla.
To describe and compare effectiveness of Genotropin, other daily hGH treatments, and Ngenla.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male and female patients of any age must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1 Prescription of Genotropin daily hGH for GHD per local diagnostic guidelines, prescription of other daily hGH treatments for GHD per local diagnostic guidelines, or prescription of Ngenla long-acting hGH per local diagnostic guidelines.
2 Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed and agree to all pertinent aspects of the study. Assent will also be sought from children of applicable age in line with national guidance. In all cases, the treating physician responsible for enrolling the patient into the registry will assess the appropriateness of gaining assent from a patient (or a legally acceptable representative) at their discretion during routine clinical care.
3 Germany only: The treating clinician has confirmed that the patient receiving a prescription treatment for GHD is eligible according to the summary of product characteristics (SmPC) indications and contraindications.
Key exclusion criteria
1. Participation in any interventional clinical trials at the time of enrollment.
Target sample size
2225
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Horikawa |
Organization
National Center for Child Health and Development
Division name
Endocrinology and Metabolism
Zip code
157-8535
Address
2-10-1 Okura,Setagaya-ku,Tokyo
TEL
03-3416-0181
JPN_PROGRES@iqvia.com
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Arata |
Organization
IQVIA Services Japan K.K.
Division name
Real-World Evidence Services
Zip code
108-0074
Address
4-10-18 Takanawa, Minato-ku, Tokyo, Japan
TEL
03-6859-9500
Homepage URL
JPN_PROGRES@iqvia.com
Sponsor or person
Institute
Pfizer Inc.
Institute
Department
Personal name
Funding Source
Organization
Pfizer Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board of National Center for Child Health and Development
Address
2-10-1 Okura,Setagaya-ku,Tokyo
Tel
03-3416-0181
JPN_PROGRES@iqvia.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During the study period, participants will collect response data from two types of PRO questionnaires.
Management information
Registered date
| 2023 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057795
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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