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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis, C Virus
• Intervention / Treatment: Drug: Ombitasvir-Paritaprevir-Ritonavir; Drug: Dasabuvir; Drug: Ribavirin

Detailed Description

The study is interventional, controlled randomized (block 2:1 case: controls) in open label.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: ERICA VILLA, Prof.; Phone Number: +39 0594224359; Email: erica.villa@unimore.it
• Study Contact Backup: Name: VERONICA BERNABUCCI, MD.; Phone Number: +39 0594223109; Email: veronica.bernabucci@libero.it

Study Locations

• Italy
  • Modena, Italy, 41124
    • Gastroenterology Unit
    • Contact: VERONICA BERNABUCCI, MD; Phone Number: +390594223109; Email: veronica.bernabucci@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Viekirax; Drug: Dasabuvir; The patient will be treated daily with Dasubavir 500 mg total dose; Other Names: Exvieria; Drug: Ribavirin; Patients will be treated with ribavirin if necessary.; Other Names: RBV
No Intervention: group untreated; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	144 weeks
Percentage of participants experiencing miscarriage	Percentage of participants experiencing miscarriage during 3 years observation post-therapy.	144 weeks

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Investigators: Principal Investigator: ERICA VILLA, Prof., Gastroenterology Unit

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis C; Hepatitis; Hepatitis, Chronic; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ribavirin; Ritonavir
• Other Study ID Numbers: HCV_AMH_16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO