Chronic hepatitis C.
Conditions
Interventions
The study will incluye 5 groups of treatment. The first one will include 30 patients treated with IFN alpha 2b plus ribavirin and a monthly dose with placebo (saline) instead of Terap C during 12 mont
Sponsors
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Adults of both genders. 2.Age between 20 and 60 years. 3.Clinical history of chronic hepatitis caused by hepatitis C virus (confirmed by liver biopsy in the last 12 months before starting the clinical study, anti-HCV positive by UMELISA VHC, HCV RNA positive by UMELOSA VHC). 4.Patients naïve to antiviral treatment. 5.HCV RNA genotype 1b. 6.Informed consent signed.
Exclusion criteria
Exclusion criteria: 1.Positive to HBV or HIV markers (HIV-1-2) of infection in serum. 2.Concomitant infection with HAV. 3.Patients with concomitant background liver disease like alcoholism, autoimmune hepatitis, toxic, Wilson´s disease, haemochromatosis, obesity. 4.Women in fertile age that use hormone-based contraceptive methods. 5.Women and men in reproductive age without contraceptive control. 6.Pregnancy and breastfeeding. 7.Chronic no-compensated disease (high blood pressure, diabetes mellitus, chronic renal insufficiency, heart insufficiency, thyroid alterations, epilepsy, cancer, severe mind depression, etc.). 8.Patients with previous diagnosis of blood alterations (leukemia, hemophilia, and others). 9.Liver histology indicating cirrhosis or hepatocellular carcinoma. 10.Clinical laboratory values indicating alterations not related to HCV. 11.Concomitant immunosuppresive disease, consumption of immunosuppresive/ immunomodulators drugs (steroids, colony stimulating factor, etc.) in the six months previous to the study. 12.Documented autoimmune disease (systemic erithematosus lupus, reumatoid arthritis, multiple sclerosis, diabetes mellitus type I, etc.). 13.Patients with background of alcoholism and/or drug addiction (in case that no consumption during the last year, considerations might be done for inclusion). 14.Patients with background heart disease. 15.Patients with abnormal renal function at the moment of recruitment. 16.Patients with background of mind-related disorders. 17.Patients with background of severe allergy (asthma degree III or IV, urticary, dermatitis, bronchitis, etc.). 18.Fever above >37.8°C, in the moment or 24 hours previous to the administration of the vaccine, or acute infectious disease not related to HCV infection suggested by clinical evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response (HCV RNA undetectable 6 months after treatment conclusion), moment of evaluation: 18 months after starting treatment. It is expected that the immunization with Terap C, concomitant with IFN alpha 2b +ribavirin, in HCV chronically infected individuals, naïve to treatment, increase in at least 20% the number of individuals with HCV RNA undetectable at 18 months after starting treatment, with respect to the control group (treatment with IFN alpha 2b +ribavirin alone). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome: Improvement in liver histology, moment of evaluation, 18 months after starting the treatment with respect to pre-treatment status. It is expected that the immunization with Terap C, concomitant with IFN Alpha 2b+ribavirin, in HCV chronically infected individuals, naïve to treatment, increase in at least 20% the number of individuals with reduction in fibrosis at 18 months after starting treatment, with respect to the control group (treatment with IFN alpha 2b+ribavirin alone) Secondary Outcome: Biochemical response (ALT, AST, creatinine, serum bilirubin, alkaline phosphatase, gamma GT), moment of evaluation, every four weeks, up to week 72 after starting the treatment. It is expected that the immunization with Terap C, concomitant with IFN alpha 2b+ribavirin, in HCV chronically infected individuals, naïve to treatment, increase in at least 20% the number of individuals with normal biochemical values at 18 months after starting treatment, with respect to the control group (treatment with IFN alpha 2b+ribavirin alone) Secondary Outcome: Safety, all adverse events detected during the first hour after immunization, or in monthly interviews up to 18 months after starting the treatment, will be recorded by using a notebook to be filled by the patients after each dose with the vaccine candidate. No serious adverse events are expected. Moment of evaluation, monthly up to 18 months after starting the treatment. | — |
Countries
Cuba
Contacts
Public ContactZurina Estevez
Department of Clinical Trials, Vaccine Division, Biomedical Research, CIGB.
Outcome results
None listed