Study identification

PURI

https://redirect.ema.europa.eu/resource/30377

EU PAS number

EUPAS17267

Study ID

30377

Official title and acronym

European Post-Authorization Registry for RAVICTI® (glycerol phenylbutyrate) Oral Liquid in Partnership with the European Registry and Network for Intoxication Type Metabolic Diseases (E-IMD) (HZNP-RAV-401)

DARWIN EU® study

No

Study countries

Austria
Denmark
France
Germany
Poland

Study description

This is a multi-center, prospective, non-interventional registry conducted by E-IMD in collaboration with Immedica Pharma designed to collect data on safety and outcomes in patients with urea cycle disorders (UCDs) on treatment with RAVICTI or patients with UCDs treated with alternative nitrogen scavenging medication other than RAVICTI.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 5 centres are involved in the study

Networks

E-IMD

Contact details

Åsa Jansson

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Immedica Pharma AB
Study protocol
Initial protocol

V3 0_RAVICTI-EU-Registry_protocol__20161129_final-clean_incl app with redaction_Redacted_sk_Redacted_sk

English (2.7 MB - PDF)View document
Updated protocol

V5 0_RAVICTI-EU-Registry_protocol__26 Apr 2018_Final Signed_Complete_Redacted (2)

English (9.18 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)