Phase 2
Completed N=50
A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
Source: ClinicalTrials.gov NCT00537407 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
May 2015
Primary outcomePrimary: Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E) — -0.881; -2.321; -2.020 Log10(IU/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Triple Therapy Treatment Arms (A, D, and E) |
-0.881; -2.321; -2.020 | — |
| SECONDARY Change From Baseline in log10 Hepatitis C Virus RNA at Day 29 in the Debio 025 Monotherapy and Dual Therapy Treatment Arms (B and C) |
0.285; -0.608 | — |
| SECONDARY log10 Hepatitis C Virus RNA at Day 29 |
5.567; 6.662; 5.827; 4.000; 4.245 | — |
| SECONDARY Percentage of Participants With a Rapid Viral Response at Day 29 |
0.0; 0.0; 0.0; 10; 10 | — |
| SECONDARY Percentage of Participants With an Early Viral Response at Week 12 |
30.0; 11.1; 27.3; 70.0; 30.0 | — |
| SECONDARY Percentage of Participants With an End-of-treatment Response at the End of Treatment (Week 48 or 72) |
20.0; 11.1; 18.2; 10.0; 30.0 | — |
| SECONDARY Percentage of Participants With a Sustained Viral Response 24 Weeks After the End of Treatment (Week 72 or 96) |
0.0; 0.0; 9.1; 0.0; 10.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients between 18 and 60 years of age.
- Hepatitis B negative and human immunodeficiency virus (HIV) negative.
- Diagnosed with hepatitis C genotype I and not responsive to treatments such as peginterferon alpha-2a or 2b and ribavirin for at least 12 weeks.
- Adequate liver function (Child-Pugh-Turcotte score A) and other laboratory parameters within acceptable range.
- Females may participate only if they cannot become pregnant, i.e., are surgically sterile, post-menopausal, or using 2 reliable contraceptive methods.
- Male patients must be surgically sterile or utilizing a barrier contraceptive method.
- For female patients of child bearing potential, negative pregnancy test within 1 week of first investigational product administration.
Exclusion Criteria
- Treatment with any investigational drug within 6 months prior to the start of the study.
- Ongoing or recent use of antiviral medication within 1 month before the start of the study.
- A known bad reaction or intolerance to Debio 025, peginterferon alpha-2a, and/or ribavirin.
- Presence or history of any severe related disease.
Data sourced from ClinicalTrials.gov (NCT00537407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.