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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis, C Virus Drug: Ombitasvir-Paritaprevir-Ritonavir Drug: Dasabuvir Drug: Ribavirin Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 Name: Viekirax

Drug: Dasabuvir
The patient will be treated daily with Dasubavir 500 mg total dose
Other Name: Exvieria

Drug: Ribavirin
Patients will be treated with ribavirin if necessary.
Other Name: RBV

No Intervention: group untreated
Control group



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Modification of AMH levels [ Time Frame: 144 weeks ]
    Modification of AMH levels before and after successful antiviral therapy

  2. 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

  3. Percentage of participants experiencing miscarriage [ Time Frame: 144 weeks ]
    Percentage of participants experiencing miscarriage during 3 years observation post-therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: ERICA VILLA, Prof. +39 0594224359 erica.villa@unimore.it
Contact: VERONICA BERNABUCCI, MD. +39 0594223109 veronica.bernabucci@libero.it

Locations
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Italy
Gastroenterology Unit
Modena, Italy, 41124
Contact: Erica Villa, Prof.    +390594225308    erica.villa@unimore.it   
Contact: VERONICA BERNABUCCI, MD    +390594223109    veronica.bernabucci@gmail.com   
Principal Investigator: Erica Villa, Prof.         
Sponsors and Collaborators
University of Modena and Reggio Emilia
Investigators
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Principal Investigator: ERICA VILLA, Prof. Gastroenterology Unit
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Responsible Party: Prof. Facchinetti Fabio, PRS administrator, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT02950870    
Other Study ID Numbers: HCV_AMH_16
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Hepatitis C
Flaviviridae Infections
Ritonavir
Ribavirin
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimetabolites