Chronic Hepatitis, C Virus
Conditions
Brief summary
The purpose of this study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment.
Detailed description
The study is interventional, controlled randomized (block 2:1 case: controls) in open label.
Interventions
DRUGOmbitasvir-Paritaprevir-Ritonavir
The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
DRUGDasabuvir
The patient will be treated daily with Dasubavir 500 mg total dose
DRUGRibavirin
Patients will be treated with ribavirin if necessary.
Sponsors
University of Modena and Reggio Emilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Female between 18 and 35 years of age at the time of Screening * Childbearing potential and sexually active with male partner(s) currently using at least one effective method of birth control at the time of screening and two effective methods of birth control while receiving study drugs, starting with Study Day 1 and for 7 months after stopping study drug. * Females must have negative results for pregnancy tests * Chronic HCV-infection prior to study enrollment * Screening laboratory result indicating HCV GT 1b or GT 1a or GT 4 infection. * Must be able to voluntarily sign and date an informed consent form * Liver biopsy within 24 months prior to or during screening demonstrating a Metavir score of 2 or less or an Ishak score of 3 or less or Screening FibroScan® result of ≤ 9.6 kPa;
Exclusion criteria
* Women who are pregnant or breastfeeding * Positive test result for HBsAg and HIV Ab * Recent history of drug or alcohol * HCV genotype performed during screening indicates more than 1 subtype or co-infection with any other genotype. * Use of medications contraindicated * Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8 * History of solid organ transplant. * Confirmed presence of hepatocellular carcinoma * Current use of any investigational or commercially available anti-HCV agents * Screening laboratory analyses showing any of the following abnormal laboratory results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The modification of AMH levels | 48 weeks post treatment | The primary outcome is to evaluate the modification of AMH levels before and after successful antiviral therapy in comparison with age-matched HCV-positive women not undergoing antiviral treatment is the primary endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modification of AMH levels | 144 weeks | Modification of AMH levels before and after successful antiviral therapy |
| Modification of the Estradiol (E2) levels | 144 weeks | Modification of the Estradiol (E2) levels before and after successful antiviral therapy in comparison with age-matched HCV-positive women not undergoing antiviral treatment is the primary endpoint |
| Percentage of participants experiencing miscarriage | 144 weeks | Percentage of participants experiencing miscarriage during 3 years observation post-therapy. |
Countries
Italy
Contacts
Primary ContactERICA VILLA, Prof.
Backup ContactVERONICA BERNABUCCI, MD.
Outcome results
None listed