Status:
WITHDRAWN
Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir, and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hepatitis C Virus Genotype 4 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of pegylated Interferon-R...
Detailed Description
The clinical trial is multi-centre, national, Phase 2, open-label, single-arm. The primary objective of this study is to assess, in HCV genotype 4-infected patients in failure to prior treatment with ...
Eligibility Criteria
Inclusion
- Adult ≥18 years
- Infection with HCV genotype 4, confirmed by detectable HCV RNA ≥ 1000 IU/ml at pre-inclusion
- Failure to a prior treatment with pegylated Interferon and Ribavirin, with failure being defined as follows:
- Non-response: HCV viral load remaining detectable during and at the end of P/R treatment.
- Relapse: undetectable HCV viral load during P/R treatment and detectable after the end of the treatment.
- HCV breakthrough: undetectable HCV viral load during P/R treatment becoming detectable before the end of treatment.
- Anti-HCV treatment discontinued for at least the last 3 months
- Fibrosis at any stage, with documentation of the presence or absence of cirrhosis at the pre-inclusion visit:
- history of liver biopsy showing cirrhosis lesions (METAVIR F4), at any time in the patient's history, or
- good quality (length ≥ 1 cm and ≥ 5 portal spaces) liver biopsy dating from less than 18 months to establish the METAVIR, or
- hepatic impulse elastometry (Fibroscan®) dating from less than 6 months and of good quality (at least 10 measurements on an incidence with IQR of less than 30% of the median elastometry measured and a success rate of 60%) or
- interpretable Fibrotest® dating from less than 6 months The proportion of patients with cirrhosis will be limited to 50% of all patients included, cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse elastometry ≥ 14 kPa or a Fibrotest® result \> 0,75.
- Men and women of a child-bearing age and their heterosexual partners must use adequate contraception during treatment and up to 8 weeks after the end of treatment for women, 12 weeks after the end of treatment for men.
- Written informed consent signed by the patient and the investigator (on the day of the pre-inclusion at the latest and before any examination required by the study) (article L1122-1-1 Public Health Code)
- Patients with Health insurance (Sécurité Sociale or Couverture Médicale Universelle)
Exclusion
- Medical history
- CHILD B or C cirrhosis
- Previous HCV therapy including HCV NS3 protease inhibitor, and/or HCV NS5A replication complex inhibitor and/or HCV NS5B polymerase inhibitor
- Current condition
- Positive HBs Antigen
- Confirmed HIV-1 or HIV-2 infection
- Pregnant or breast-feeding women
- Transplant recipients
- Any evolutive ongoing malignant disease, including hepatocellular carcinoma, which will be specifically screened for before inclusion
- Consumption of alcohol which, in the investigator's opinion, will be an obstacle to the patient's participation and to his/her remaining in the study
- Drug addiction which, in the investigator's opinion, will be an obstacle to the patient's participation and to his/her remaining in the study. Patients included in a programme of substitution with methadone or buprenorphine could be included. The opinion of an addictology consultant is recommended for patients presenting with current drug use or drug use in the past year.
- Patients taking part in another clinical trial during the 30 days prior to inclusion
- Patient under guardianship, trusteeship or judicial protection
- Biological criteria
- ALT ≥ 5xULN
- Total bilirubin ≥ 34 µmol/L, unless a documented history of Gilbert's disease
- Hb \< 85 g/L
- Platelets \< 50 000/mm3
- Kidney failure defined by creatinine clearance \< 50mL/mn (MDRD formula)
- QTc \> 440 msec for males or 460 msec for females
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02309450
Start Date
December 1 2014
End Date
August 1 2016
Last Update
February 2 2016
Active Locations (1)
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1
France
All the Regions of the Country, France