Hepatitis C Virus Genotype 4 Infection Clinical Trial
Official title:
Pilot Study to Assess Efficacy and Safety of a Quadruple Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Non-responders to Pegylated Interferon-Ribavirin Regimen
Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients
infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard
treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination
with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment
in non-responders genotype 1-infected patients.
Given the absence of current solutions and urgent therapeutic needs for HCV genotype
4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study
aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir,
Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat
population.
60 subjects will be enrolled.
The primary endpoint will be the rate of sustained virological response (SVR), defined by an
undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).
The population studied presents the maximum of factors of non-response to the retreatment of
hepatitis C: non-response to well followed prior treatment with pegylated Interferon and
Ribavirin, infection with HCV genotype 4, and the presence of cirrhosis (in less than 50% of
the included patients) that could diminish the chances of SVR to a standard bitherapy.
The likelihood of SVR with standard bitherapy in this study population is thus considered
low, around 15%.
The principal objective of this multicentric, national, single-arm, open-labeled,
non-randomized phase II pilot study in 60 patients, is to assess the rate of SVR 12 weeks
after 24 weeks of quadritherapy and to determine whether this rate is significantly greater
than 20%.
The proportion of patients presenting with cirrhosis (defined by a METAVIR F4 score on liver
biopsy or with hepatic impulse elastometry ≥ 15 kPa) will be limited to 50% of all patients
included.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02309450 -
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
|
Phase 2 |