Phase II clinical trial for the evaluation of the therapeutic vaccine candidate Terap C.
- Conditions
- Chronic hepatitis C.
- Registration Number
- RPCEC00000074
- Lead Sponsor
- Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method