Study identification

EU PAS number

EUPAS16927

Study ID

45599

Official title and acronym

PAR-R13-001: PARADIGHM (Physicians Advancing Disease Knowledge in Hypoparathyroidism): A Registry for Patients with Chronic Hypoparathyroidism

DARWIN EU® study

No

Study countries

Austria
Canada
Denmark
Germany
Greece
Italy
Norway
Spain
Sweden
United Kingdom
United States

Study description

The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH1-84) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice. Participants will be treated according to their clinic’s standard practice determined by the treating doctors. Each participant will fill out a study questionnaire during a routine doctor visit.

Study status

Ongoing
Research institutions and networks

Institutions

Takeda
First published:
01/02/2024
Institution

Contact details

Study Contact Takeda

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Shire
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)

Regulatory procedure number

EMEA/H/C/PSP/S/0058.1