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

Primary Purpose

Chronic Hepatitis, C Virus

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ombitasvir-Paritaprevir-Ritonavir
Dasabuvir
Ribavirin
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis, C Virus

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gastroenterology Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group treated

group untreated

Arm Description

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.

Control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Modification of AMH levels
Modification of AMH levels before and after successful antiviral therapy
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
Percentage of participants experiencing miscarriage
Percentage of participants experiencing miscarriage during 3 years observation post-therapy.

Full Information

First Posted
October 26, 2016
Last Updated
October 27, 2016
Sponsor
University of Modena and Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT02950870
Brief Title
Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
The study is interventional, controlled randomized (block 2:1 case: controls) in open label.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis, C Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group treated
Arm Type
Experimental
Arm Description
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.
Arm Title
group untreated
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
Ombitasvir-Paritaprevir-Ritonavir
Other Intervention Name(s)
Viekirax
Intervention Description
The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
Intervention Type
Drug
Intervention Name(s)
Dasabuvir
Other Intervention Name(s)
Exvieria
Intervention Description
The patient will be treated daily with Dasubavir 500 mg total dose
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
RBV
Intervention Description
Patients will be treated with ribavirin if necessary.
Primary Outcome Measure Information:
Title
The modification of AMH levels
Description
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
Time Frame
48 weeks post treatment
Secondary Outcome Measure Information:
Title
Modification of AMH levels
Description
Modification of AMH levels before and after successful antiviral therapy
Time Frame
144 weeks
Title
Modification of the Estradiol (E2) levels
Description
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
Time Frame
144 weeks
Title
Percentage of participants experiencing miscarriage
Description
Percentage of participants experiencing miscarriage during 3 years observation post-therapy.
Time Frame
144 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ERICA VILLA, Prof.
Phone
+39 0594224359
Email
erica.villa@unimore.it
First Name & Middle Initial & Last Name or Official Title & Degree
VERONICA BERNABUCCI, MD.
Phone
+39 0594223109
Email
veronica.bernabucci@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ERICA VILLA, Prof.
Organizational Affiliation
Gastroenterology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology Unit
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Villa, Prof.
Phone
+390594225308
Email
erica.villa@unimore.it
First Name & Middle Initial & Last Name & Degree
VERONICA BERNABUCCI, MD
Phone
+390594223109
Email
veronica.bernabucci@gmail.com
First Name & Middle Initial & Last Name & Degree
Erica Villa, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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