Status:
COMPLETED
Efficacy and Safety of Narlaprevir Used in Combination With Ritonavir in Treatment-Naïve and Failed Prior Treatment With Pegylated Interferon/Ribavirin Patients With Chronic Hepatitis C Genotype 1 (PIONEER - Study)
Lead Sponsor:
R-Pharm
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to confirm that combination of narlaprevir (NVR) and ritonavir (RTV) used as a metabolic inhibitor with pegylated interferon (PEG-INF) and ribavirin (RBV) leads to a supe...
Detailed Description
The study included 3 time periods: * Screening period with duration up to 3 weeks during which study eligibility was confirmed. * Double-blind treatment period: all eligible patients divided into Tre...
Eligibility Criteria
Inclusion
- Body weight ≥ 40 and ≤ 125 kg;
- Documented infection with HCV genotype 1 (Mixed infections with other genotypes are not eligible):
- treatment naïve (to interferon and ribavirin); or
- treatment failure patients (patients must have received interferon/ribavirin at standard doses for a minimum of 12 weeks);
- Minimum HCV-RNA level of ≥10,000 IU at baseline;
- No evidence of cirrhosis; availability at Baseline of at least one of the following tests negative results:
- Liver biopsy showing no cirrhosis (not later than within 3 years prior to Baseline) or
- FibroScan elasticity score \< 12.5 kPa 12 months prior to baseline or
- FibroTest \< 0.75 12 months prior to baseline and aspartate aminotransferase (AST)/platelet ratio (APRI) of ≤ 1 during screening
- Using acceptable contraception methods for both partners from enrollment into the study until 6 months following the end of treatment;
- Willingness to give written informed consent.
Exclusion
- Previous treatment with any HCV NS3-specific protease inhibitor and/ or other direct antiviral agents (e.g. HCV polymerase inhibitors);
- Treatment for HCV infection 30 days before the enrolment;
- Use of prohibited medications within 2 weeks prior to start of study medications (inducers or substrates of CYP3A4);
- Findings suspicious for hepatocellular carcinoma (HCC);
- Hepatic failure at present or in history;
- Auto-immune hepatitis in history;
- Anti-nuclear antibodies (ANA) titers \> 1:320;
- Evidence of gallstones, choledocholithiasis and calcified gallbladder;
- HBsAg positive;
- HIV positive;
- Serum hemoglobin of \<13g/dL for males and \<12g/dL for females;
- Neutrophils \<1500/mm3 (\<1,5х109/L) at Screening;
- Platelets \<150000/mm3 (\<150х109/L) at Screening (patients with a platelet count \>100,000/mm3 (\>100х109/L) but less than 150,000/mm3 (150х109/L) can be included in the study in case a Fibroscan or FibroTest or liver biopsy during the study screening period shows no cirrhosis)
- Total bilirubin \>1.6 mg/dL (\>27.36 µmol/L) unless history of Gilbert's disease. If Gilbert's disease is the proposed etiology, this must be documented in the subject's chart;
- Direct bilirubin \>1.5 x upper limit of normal (ULN) of the laboratory reference range at Screening;
- Serum albumin \< lower limit of normal (LLN) of laboratory reference range at Screening;
- Serum creatinine \>ULN of the laboratory reference at Screening;
- Serum aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \>5 x ULN of the laboratory reference range at Screening;
- Thyroid stimulating hormone (TSH) \>1.2 ULN or \<0.8 LLN;
- Contraindications to pegylated interferon, ribavirin and/or ritonavir treatment;
- Hypersensitivity to any of the study drugs;
- Active or suspected cancer;
- Psychiatric disease (moderate or severe depression, schizophrenia, bipolar disorder et al);
- Previous suicide attempt or suicidal ideation;
- Drug addiction;
- Opiate agonist substitution therapy;
- History of active gout within the past year;
- Organ transplant (except of cornea and hair transplant);
- Pregnant or nursing women;
- Men whose female partners are pregnant or planning pregnancy;
- Any medical condition that could interfere with the patient's participation and completion of the study;
- Use of other investigational drugs/ participation in other clinical trial within 30 days before the enrolment.
Key Trial Info
Start Date :
May 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2017
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT03833362
Start Date
May 7 2014
End Date
February 21 2017
Last Update
February 7 2019
Active Locations (20)
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1
South-Ural State Medical University, Clinic of Medical Academy, Infectious Diseases Department
Chelyabinsk, Russia
2
Kazan State Medical Academy, Republican Clinical Hospital of Infectious Diseases n.a. A.F. Agafonov
Kazan', Russia
3
Federal Budget Science Institution Central Science and Research Institute of Epidemiology of RosPotrebNadzor
Moscow, Russia
4
Federal State Budget Healthcare Institution Central Clinical Hospital of Russian Academy of Science
Moscow, Russia