Chronic Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, HCV Genotype I infection, Liver disease
Brief summary
This study aims to evaluate whether an investigational monoclonal antibody, CT-011, is safe to give and if it helps patients with hepatitis C virus (HCV). Monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). Results of this trial will help doctors obtain additional information with regard to the safety and efficacy of CT-011 as a potential treatment for HCV.
Interventions
DRUGCT-011
CT-011
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
CureTech Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is between 18 and 60 years of age, both genders. 2. Biopsy proven infection with Hepatitis C genotype 1. 3. Positive for anti-HCV. 4. Chronically infected for at least 3 months from diagnosis. 5. ECOG performance status ≤ 1. 6. Previous therapy with interferon +/- Ribavirin or Peginterferon +/- Ribavirin or ineligibility for this type of therapy or for liver transplantation.
Exclusion criteria
1. Patients who received any type of anti viral treatment during the 3 months prior to enrollment. 2. Any history or active malignancy. 3. History of major organ transplantation with an existing functional graft. 4. Patients who received any systemic concurrent therapy within the last 4 weeks. 5. Patients progressing to acute liver failure (ALF).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of CT-011 in patients with Chronic Hepatitis C due to HCV Genotype I infection | 12 months |
Countries
Israel
Outcome results
None listed