Chronic Hepatitis C Clinical Trial
Official title:
An Open-label, Randomized, 5-arm, Parallel-group Study of the Effects on Viral Kinetics, Safety and Pharmacokinetics of Different Dosing Regimens of Debio 025 in Combination With Peginterferon Alpha-2a and Ribavirin in Chronic HCV Genotype 1 Patients Who Are Non Responders to Standard Peginterferon Alpha and Ribavirin Treatment
Debio 025 (alisporivir) is an oral cyclophilin inhibitor with a new mechanism of action
demonstrating potent anti-hepatitis C virus (HCV) activity in pre-clinical models and
patients.
The current standard of care (SOC) in HCV patients consists of a combination of peg-IFN
alpha and ribavirin. Treatment duration and ribavirin dose depend on the genotype treated.
Only 40-50% of patients with genotype 1 achieve a sustained viral response (SVR). This study
assesses whether Debio 025 administered in combination with peg-IFN alpha 2a and ribavirin
can improve the outcome of treatment in this group of patients.
This is a multicentre, open-label, randomized, 5 arm parallel-group, multiple dose study in
50 chronic hepatitis C virus (HCV) genotype 1 non-responders to standard treatment with
peg-IFN alpha (2a or 2b) and ribavirin. The entire study lasts a maximum of 96 weeks and
consists of a 48- or 72-week treatment period (according to response). A follow-up visit to
assess the sustained viral response (SVR) takes place 24 weeks after treatment cessation,
i.e., at study Week 72 or 96, or earlier for discontinued study participants.
There were 2 parts in the treatment period. Part 1 lasted from Day 1 to Day 29 (Weeks 1 to
4); Part 2 lasted from Week 5 to Week 48 or 72.
During Part 1 of treatment (Weeks 1 to 4), participants are randomized to 1 of 5 treatment
arms and receive 4 weeks of Debio 025 (alisporivir) monotherapy, Debio 025 combined with
standard dose peg-IFNα2a, or 1 of 3 triple therapies combining different doses of Debio 025
with peg-IFNα2a and ribavirin at standard doses.
During Part 2 of treatment (Weeks 5 to 48 or 72), participants receive standard doses of
peg-IFNα2a/ribavirin dual therapy for 44 or 68 weeks, depending on their response to
treatment. At Week 12, participants who do not achieve ≥ 2 log10 decrease in HCV RNA are
withdrawn and considered treatment failures. Participants who have undetectable HCV RNA
levels and/or ≥ 2 log10 decrease in HCV RNA continue treatment until Week 24. At Week 24,
participants who still have detectable HCV RNA levels are withdrawn and considered treatment
failures. Participants with undetectable HCV RNA levels at Weeks 12 and 24 continue
treatment until Week 48. At Week 24, "slow responders" (defined as participants with a
detectable, but > 2 log10 decrease in HCV RNA levels at Week 12 and undetectable levels at
Week 24) are eligible to continue treatment until Week 72.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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