Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.
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|ClinicalTrials.gov Identifier: NCT02950870|
Recruitment Status : Unknown
Verified October 2016 by Prof. Facchinetti Fabio, University of Modena and Reggio Emilia.
Recruitment status was: Not yet recruiting
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis, C Virus||Drug: Ombitasvir-Paritaprevir-Ritonavir Drug: Dasabuvir Drug: Ribavirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2019|
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.
The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
Other Name: Viekirax
The patient will be treated daily with Dasubavir 500 mg total dose
Other Name: Exvieria
Patients will be treated with ribavirin if necessary.
Other Name: RBV
No Intervention: group untreated
- The modification of AMH levels [ Time Frame: 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
- Modification of AMH levels [ Time Frame: 144 weeks ]Modification of AMH levels before and after successful antiviral therapy
- Modification of the Estradiol (E2) levels [ Time Frame: 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 [ Time Frame: 144 weeks ]Percentage of participants experiencing miscarriage during 3 years observation post-therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950870
|Contact: ERICA VILLA, Prof.||+39 firstname.lastname@example.org|
|Contact: VERONICA BERNABUCCI, MD.||+39 email@example.com|
|Principal Investigator:||ERICA VILLA, Prof.||Gastroenterology Unit|