Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT02907996 - Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Completed NCT01396005 - A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123) Phase 1
Completed NCT01428063 - Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials Phase 2
Completed NCT01195181 - Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice. Phase 4
Completed NCT00219999 - Hepatitis C Virus and the Humoral Immune System N/A
Completed NCT02243293 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection Phase 2/Phase 3
Completed NCT02265237 - A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1) Phase 3
Not yet recruiting NCT06104046 - Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis
Completed NCT02604017 - A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection Phase 3
Withdrawn NCT00947245 - Japanese Bridging Study Conducted in the United States Phase 1
Completed NCT01713283 - Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection Phase 2
Completed NCT01479881 - A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus Phase 1
Completed NCT01458535 - A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Phase 2
Completed NCT01193361 - Ph IIA Study (SOC +/- NS5B) Phase 2
Completed NCT01241773 - TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir Phase 1
Completed NCT01006031 - Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4 Phase 2/Phase 3
Completed NCT00819026 - Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors N/A
Completed NCT00382798 - Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin Phase 1/Phase 2
Completed NCT02592057 - Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India