A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00537407
• Date of registration: 28/09/2007
• Primary sponsor: Debiopharm S.A.
• Public title: A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
• Scientific 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
• Date of first enrolment: November 2007
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00537407
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Raf Crabbé, MD
• Affiliation: Debiopharm Group SA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female patients between 18 and 60 years of age

- Hepatitis B negative and HIV negative

- Diagnosed with Hepatitis C genotype I, not responsive to treatments such as
peginterferon alpha-2a or 2b and ribavirin for at least 12 weeks

- Adequate liver function (CPT 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 one
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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C

Intervention(s)

Drug: Debio-025

Primary Outcome(s)

Log10 HCV RNA change from baseline [Time Frame: after 29 days of therapy]

Secondary Outcome(s)

Viral response rates, Safety parameters,Drug pharmacokinetics. [Time Frame: weeks 4, 12, 24 after end of treatment]

Secondary ID(s)

Debio 025-HCV-207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors