Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.

Phase 4

• Conditions: Chronic Hepatitis, C Virus
• Interventions: Drug: Ombitasvir-Paritaprevir-Ritonavir; Drug: Dasabuvir; Drug: Ribavirin

• Registration Number: NCT02950870
• Lead Sponsor: University of Modena and Reggio Emilia

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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-27
• Last Update Submitted: 2016-10-27
• Study First Posted: 2016-11-01
• Last Update Posted: 2016-11-01
• Study Start: 2016-12
• Primary Completion: 2017-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group treated	Ombitasvir-Paritaprevir-Ritonavir	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 treated	Dasabuvir	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 treated	Ribavirin	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Gastroenterology Unit; 🇮🇹 Modena, Italy