Study identification

EU PAS number

EUPAS37342

Study ID

48456

Official title and acronym

POST AUTHORIZATION SAFETY STUDY OF FEXINIDAZOLE FOR HUMAN AFRICAN TRYPANOSOMIASIS : Analysis of real-life safety and effectiveness data on fexinidazole, collected by NSSCP & WHO as part of NSSCP activity as per WHO interim guidelines 2019 (FEXINC09395)

DARWIN EU® study

No

Study countries

Anguilla
Burkina Faso
Cameroon
Central African Republic
Chad
Congo
Congo, The Democratic Republic of the
Côte d’Ivoire
Equatorial Guinea
Gabon
Ghana
Guinea
Mali
Nigeria
South Sudan
Uganda

Study description

The PASS is based on the analysis of the data prospectively collected by the NSSCP/WHO PHP in selected sub-Saharan African countries as per WHO guidelines adopted by NSSCP. This safety evaluation is considered as an additional Pharmacovigilance activity and is included in the Pharmacovigilance Plan as a Category 3 Post Authorization Safety Study (PASS). The primary objective of this PASS is to assess the safety of fexinidazole in field conditions of use. The secondary objective is to assess effectiveness of fexinidazole, in real life use by evaluating occurrence of relapse at 12 and 24 months of follow-up.

Study status

Planned
Research institutions and networks

Institutions

Sanofi
First published:
01/02/2024
Institution

Contact details

Trial Transparency Team Team

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
Regulatory

Was the study required by a regulatory body?

No

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

EU RMP category 3 (required)