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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.
The study is interventional, controlled randomized (block 2:1 case: controls) in open label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group treated | Experimental | 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. |
|
| group untreated | No Intervention | Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ombitasvir-Paritaprevir-Ritonavir | Drug | The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Modification of AMH levels | Modification of AMH levels before and after successful antiviral therapy | 144 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ERICA VILLA, Prof. | Contact | +39 0594224359 | erica.villa@unimore.it | |
| VERONICA BERNABUCCI, MD. | Contact | +39 0594223109 | veronica.bernabucci@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| ERICA VILLA, Prof. | Gastroenterology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Unit | Modena | Modena | 41124 | Italy |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C588260 | dasabuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Dasabuvir | Drug | The patient will be treated daily with Dasubavir 500 mg total dose |
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| Ribavirin | Drug | Patients will be treated with ribavirin if necessary. |
|
|
| 144 weeks |
| Percentage of participants experiencing miscarriage | Percentage of participants experiencing miscarriage during 3 years observation post-therapy. | 144 weeks |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |