Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
The study is interventional, controlled randomized (block 2:1 case: controls) in open label.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: group treated this group will be treated with Ombitasvir-Paritaprevir-Ritonavir (12,5 mg/75 mg/50 mg) and Dasabuvir ( 250 mg) with or without Ribavirina every day , for 12 weeks. |
Drug: Ombitasvir-Paritaprevir-Ritonavir
The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
Other Names:
Drug: Dasabuvir
The patient will be treated daily with Dasubavir 500 mg total dose
Other Names:
Drug: Ribavirin
Patients will be treated with ribavirin if necessary.
Other Names:
|
| No Intervention: group untreated Control group |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gastroenterology Unit | Modena | Italy | 41124 |
Sponsors and Collaborators
- University of Modena and Reggio Emilia
Investigators
- Principal Investigator: ERICA VILLA, Prof., Gastroenterology Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCV_AMH_16