Viewing Protocol Section

Viewing Protocol Section

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Clinical Trials

To give you an idea of how we make custom software. We have taken all of the Clinical Trials Information from our Federal Government(https://clinicaltrials.gov/).

The JSON File Structure of the files is as follows: Full Study -> Study => Sections => Modules. You are currently viewing a Protocol Section and its Modules.

We give the table structure here to give you an idea of what you are looking at. We put the explanation to the left and the data to the right.

A Protocol Section has the following Modules.

1. Identification Module

2. Status Module

3. Sponsor Collaborators Module

4. Oversight Module

5. Description Module

6. Conditions Module

7. Design Module

8. Arms Interventions Module

9. Outcomes Module

10. Eligibility Module

11. Contacts Locations Module

12. References Module

13. IPD Sharing Statement Module

Viewing Protocol Section


Ignite Creation Date: 2024-05-06 @ 8:26 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06383403
Protocol Section: NCT06383403
Start Identification Module Data
Brief Title: A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid
Official Title: A Phase IIIb Randomised Parallel-Group Double-Blind Placebo-Controlled Two-Arm Study to Evaluate the Effect of Elafibranor 80 mg on Normalisation of Alkaline Phosphatase in Adult Participants With Primary Biliary Cholangitis PBC and Inadequate Response or Intolerance to Ursodeoxycholic Acid
Acronym: ELSPIRE
Organization: Ipsen
Organization Class: INDUSTRY
Organization Study ID: CLIN-60190-463
Secondary IDs
Secondary ID Type Domain Link
2024-510695-20-00 CTIS None None
Start Status Module Data
Status Verified Date: 2024-09
Overall Status: RECRUITING
Study First Submit Date:
Study First Submit QC Date:
Last Update Submit Date:
Status:
Start Sponsor Collaborators Module Data
Investigator:
Lead Sponsor: Ipsen
Lead Sponsor Class: INDUSTRY
Lead Sponsor: Ipsen
Start Oversight Module Data
Description Module:
Study Last Update Post Date Type(Status Module):
Attachment: Upload