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

University of Modena and Reggio Emilia

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis, C Virus

Treatments: Drug: Dasabuvir; Drug: Ombitasvir-Paritaprevir-Ritonavir; Drug: Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02950870

HCV_AMH_16

Details and patient eligibility

About

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.

Full description

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

Enrollment: 75 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

group treated

Experimental group

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.

Treatment:

Drug: Ribavirin

Drug: Ombitasvir-Paritaprevir-Ritonavir

Drug: Dasabuvir

group untreated

No Intervention group

Description:

Control group