chronic HCV infection MedDRA version: 12.1 Level: LLT Classification code 10019183 Term: HCV
Conditions
Interventions
Trade Name: Copegus
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIBAVIRIN
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is at least 18 years at screening. 2. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 3. Subject has been treated with RBV and PEG-IFN for a chronic HCV infection for at least 4 weeks 4. Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or female subject is of childbearing potential practicing adequate contraception, e.g. intrauterine device, hormonal contraceptives, sponge, foams, jellies, diaphragm all in combination with condom use by the sexual partner; double barrier method, vasectomized partner, or total abstinence. They must agree to take precautions in order to prevent a pregnancy throughout the entire study and until four months after the end of this study. 5. Male subject is practicing one of the following methods of birth control during this study with RBV and for seven months after the end of the study: condoms, is vasectomized or total abstinence from sexual intercourse. Next to that, the female sexual partner should practice an adequate contraception method. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to understand the nature and extent of the trial and the procedures required. 2. Participation in a drug trial within 60 days prior to the first dose. 3. RBV use within 90 days prior to the first dose. 4. Pregnancy or a pregnant partner (unless subject agrees to use condoms) 5. Hemoglobin (Hb) 35 µmol/L or albumin 4 sec or platelets < 90 x 109/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if adequate exposure to ribavirin can be achieved after a dose adjustment based on the AUC0-4h from a first dose of ribavirin.;Secondary Objective: - To evaluate how many patients need a dose adjustment to achieve adequate exposure to ribavirin - To evaluate if there are subgroups of HCV infected patients who more often need a dose adjustment to achieve sufficient exposure to ribavirin - To evaluate the safety and tolerability of a dose adjustment of ribavirin in (formerly) HCV infected patients ;Primary end point(s): The primary outcome is the proportion of patients with an AUC0-4h in the target range with the second dose within this study. | — |
Countries
Germany, Netherlands
Outcome results
None listed