A PHASE III, OPEN-LABEL, MULTICENTRIC CLINICAL TRIAL OF A SINGLE ARM OF 16 LENGTHS OF TIME TO EVALUATE RETENTION WITH ELBASVIR / GRAZOPREVIR PLUS SOFOSBUVIR AND RIBAVIRIN IN PATIENTS WITH HEPATITIS C CHRONIC GENOTYPES 1.4 WHO HAVE FAILED TO TREAT WITH A REGIME BASED ON AN INHIBITOR OF THE NS5A

Phase 1

• Conditions: HCV infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-000432-34-ES
• Lead Sponsor: Fundación SEIMC-GESIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-21
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Adults with chronic HCV genotype 1, 4 infection with or without HIV infection aged 18 years or above
- Concentration of HCV RNA plasma of at least 1000 IU / mL
- Subjects previously treated with NS5A-based regimens for at least 8 weeks.
- Patients with HCV relapse after receiving a complete treatment with NS5A-based AAD regimen for at least 8 weeks and becoming undetectable at the end of treatment. Relapse is defined as a confirmed HCV RNA detectable upon completion of NS5A-based AAD therapy against HCV.
- Subjects with compensated hepatic cirrhosis (Child A) could be included.
- For patients with HIV coinfection:
- Being infected with HIV-1, documented by any HIV rapid test with the corresponding license and confirmed by a Western blot or second antibody test using a method other than the initial rapid HIV method and / or E / CIA or By HIV-1 p24 antigen or viral load of HIV-1 RNA plasma.
- Be on stable HIV antiretroviral therapy (ART) for at least 4 weeks prior to entry into the study using a dual ITN backbone of tenofovir or abacavir and emtricitabine or lamivudine PLUS raltegravir or dolutegravir or rilpivirine (with CD4 + > 100 cells / mm 3 and undetectable HIV-1 RNA at baseline. Results from prior analysis will be accepted within 24 weeks prior to study entry).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Subjects with hepatitis other than C or steatosis.
- Subjects previously treated less than 8 weeks with regimens based on NS5A.
- Evidence of previous hepatocellular carcinoma although it has criteria of cure
- Subjects with past or current decompensated liver disease; Only decompensated patients who have received a liver transplant and have not decompensated after transplantation will be included.
- Subjects suspected of clinical or genotypic reinfection of HCV.
- Subject with HCV response regrowth while receiving NS5A-based ADA therapy against HCV. Said regrowth is defined as a confirmation of detectable HCV RNA after achieving undetectable HCV RNA during NS5A-based ADA therapy against HCV.
- Recent history of drug or alcohol abuse.
- Important comorbidities.
- Pregnant women, breastfeeding, or women who do not use contraceptive methods, if they are women of childbearing age. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.
- Subjects with a glomerular filtration rate lower than 30 ml / min.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified