NCT02950870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 26, 2016

Last Update Submit

October 27, 2016

Conditions

Chronic Hepatitis, C Virus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Modification of AMH levels

    144 weeks

  • Modification of the Estradiol (E2) levels

    144 weeks

  • Percentage of participants experiencing miscarriage

    144 weeks

Study Arms (2)

group treated

EXPERIMENTAL

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-RitonavirDrug: DasabuvirDrug: Ribavirin

group untreated

NO INTERVENTION

Control group

Interventions

Ombitasvir-Paritaprevir-RitonavirDRUG

The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose

Also known as: Viekirax
group treated
DasabuvirDRUG

The patient will be treated daily with Dasubavir 500 mg total dose

Also known as: Exvieria
group treated
RibavirinDRUG

Patients will be treated with ribavirin if necessary.

Also known as: RBV
group treated

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Unit

Modena, Modena, 41124, Italy

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

dasabuvirRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • ERICA VILLA, Prof.

    Gastroenterology Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ERICA VILLA, Prof.

CONTACT

+39 0594224359erica.villa@unimore.it

VERONICA BERNABUCCI, MD.

CONTACT

+39 0594223109veronica.bernabucci@libero.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PRS administrator

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 1, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)