Chronic Hepatitis, C Virus Clinical Trial
Official title:
An Open-Label Study to Evaluate Long-Term Outcomes With Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Fertile Women With Genotype 1 and 4 Chronic Hepatitis C Virus (HCV) Infection
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.
| Status | Not yet recruiting |
| Enrollment | 75 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 35 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Gastroenterology Unit | Modena |
| Lead Sponsor | Collaborator |
|---|---|
| University of Modena and Reggio Emilia |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The modification of AMH levels | 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 | 48 weeks post treatment | No |
| Secondary | Modification of AMH levels | Modification of AMH levels before and after successful antiviral therapy | 144 weeks | No |
| Secondary | Modification of the Estradiol (E2) levels | 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 | 144 weeks | No |
| Secondary | Percentage of participants experiencing miscarriage | Percentage of participants experiencing miscarriage during 3 years observation post-therapy. | 144 weeks | No |