Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.
NCT ID: NCT02950870
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
75 participants
INTERVENTIONAL
2016-12-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Ombitasvir-Paritaprevir-Ritonavir
The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
Dasabuvir
The patient will be treated daily with Dasubavir 500 mg total dose
Ribavirin
Patients will be treated with ribavirin if necessary.
group untreated
Control group
No interventions assigned to this group
Interventions
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Ombitasvir-Paritaprevir-Ritonavir
The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
Dasabuvir
The patient will be treated daily with Dasubavir 500 mg total dose
Ribavirin
Patients will be treated with ribavirin if necessary.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
FEMALE
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Responsible Party
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Prof. Facchinetti Fabio
PRS administrator
Principal Investigators
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ERICA VILLA, Prof.
Role: PRINCIPAL_INVESTIGATOR
Gastroenterology Unit
Locations
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Gastroenterology Unit
Modena, Modena, Italy
Countries
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Central Contacts
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Facility Contacts
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Erica Villa, Prof.
Role: primary
VERONICA BERNABUCCI, MD
Role: backup
Other Identifiers
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HCV_AMH_16
Identifier Type: -
Identifier Source: org_study_id