Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin
Information source: Transition Therapeutics
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C; Hepatitis, Viral, Human
Intervention: EMZ702 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Transition Therapeutics Official(s) and/or principal investigator(s):
Aleksandra Pastrak, M.D., Study Director, Affiliation: Transition Therapeutics
Summary
The purpose of this study is to assess the safety and efficacy of repeated intravenous
infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with
chronic hepatitis C genotype 1.
Clinical Details
Official title: An Open Label, Dose Escalation Study of EMZ702 in Combination With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Non-responsive to Prior Therapy With Pegylated Interferon and Ribavirin
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the safety and tolerability of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1
Secondary outcome: To evaluate the viral response and pharmacokinetic profile of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1
Detailed description:
In this study, 28 patients with chronic hepatitis C genotype 1 who have failed previous
treatment with pegylated interferon plus ribavirin will be treated. The study treatment
will consist of the same type and doses of pegylated interferon and ribavirin to which the
patient failed to respond plus EMZ702. EMZ702 will be administered intravenously twice a
week during the first 12 weeks of treatment. Thereafter and according to viral response,
patients will continue to receive pegylated interferon and ribavirin only for up to 36
weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hepatitis C virus (HCV) genotype 1
- Previous therapy with pegylated interferon and ribavirin
- Documented previous treatment failure
Exclusion Criteria:
- Hepatic dysfunction
- Coinfection with hepatitis B or HIV
- Other unrelated liver diseases
- Liver cancer
Locations and Contacts
L.H.S.C. University Campus, London, Ontario N6A 5A5, Canada
Ottawa Hospital, Ottawa, Ontario, Canada
Additional Information
Starting date: August 2005
Last updated: June 4, 2013
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