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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02893046
Other study ID # RARS 28
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 25, 2016
Last updated September 1, 2016
Start date September 2016
Est. completion date September 2019

Study information

Verified date August 2016
Source Assistance Publique - Hôpitaux de Paris
Contact Stéphanie DOMINGUEZ, MD
Phone (0)1 49 81 25 26
Email stephanie.dominguez@aphp.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

The main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick and effective access to diagnosis and treatment of HCV by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.


Description:

The current estimation of infected persons with chronic hepatitis C in France is over 200 ,000. It appears that prevention, screening, care management, medical and social care of patients can be significantly improved especially among the most vulnerable populations. Indeed, these new HCV infections are mediated by drug-using people, prisoners, migrants, men who have sex with men (MSM) and who are supported too late and without real access to treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date September 2019
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years old and more

- Positive Hepatitis C virus

- Patient having expressed a non-objection to participate in this research

Exclusion Criteria: None

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
No intervention


Locations

Country Name City State
France Henri Mondor Hospital Creteil

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Agence Regionale de Sante Ile de France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients effectively cared divided by number of patients eligible to care. Year 3 No
Secondary Number of patients cared in the HCV care pathway in Ile-de-France Year 3 No
Secondary Number of patients effectively treated divided by number of patients eligible to DAA treatment. Year 3 No
Secondary Delay between HCV diagnosis and early consultation Year 3 No
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