Chronic Hepatitis C, Hepatitis, Viral, Human
Conditions
Keywords
hepatitis C, genotype 1, non-responders, viral hepatitis
Brief 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.
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.
Interventions
DRUGEMZ702
Sponsors
OPKO Health, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed