DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection (NCT02772003) | Clinical Trial Compass
Active — Not RecruitingPhase 1
DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection
United States, Puerto Rico33 participantsStarted 2016-06-06
Plain-language summary
This phase I trial studies the side effects and best dose of deoxyribonucleic acid (DNA) vaccine therapy in treating patients with hepatitis C virus (HCV) infection that persists or progresses over a long period of time. Vaccines made from DNA may help the body build an effective immune response to kill cancer cells that express HCV infection.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PRE-REGISTRATION INCLUSION CRITERIA
* Presence of active, chronic HCV infection confirmed by positive HCV RNA
* Willingness to use adequate contraception to avoid pregnancy or impregnation for the duration of study participation; Note:
* The effects of INO-8000 with or without INO-9012 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
* For men and women who are not postmenopausal (i.e., \>= 12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone \[FSH\], if not on hormone replacement) or surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females), agreement to remain abstinent or use highly effective or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and at least through week 12 after last dose
* Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
* Examples of contraceptive methods with an expected failure rate of \< 1% per year include male sterilization and hormonal implants; alternat…
What they're measuring
1
Incidence of dose-limiting toxicity
Timeframe: Baseline to 26 weeks
2
Mean change of interferon-gamma production by peripheral blood mononuclear cells