Protecting immune responses in patients treated with the new DAA anti hepatitis C alone or in combination with previously used medications (interferon and ribavirin)

Phase 1

• Conditions: CHRONIC HEPATITIS C; MedDRA version: 20.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-003024-31-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-27
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Male or female, age = 18 years
2.Evidence of genotype 1 HCV infection (molecular assay)
3.Quantifiable plasma HCV RNA
4.Documented mild or moderate liver fibrosis (Metavir F0-F3 or Ishak 0-4) assessed by liver biopsy in the past 24 months or by FibroScan™/Elastography (< 12.5 kPa)
5.No prior treatment for hepatitis C with any approved or investigational drug
6.If women of childbearing potential, negative serum¿¿ human chorionic gonadotropin (¿ hCG) or urine pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure the lack of pregnancy at the time of starting treatment.
7.If heterosexually active female of childbearing potential or nonvasectomized male subject with a female partner of childbearing potential, use of 2 effective contraceptives starting with screening and for 7 months after stopping drugs.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Infection or coinfection with HCV of another genotype than genotype 1
2.Contraindication to the administration of Peg-IFN-alfa or RBV, or medical history or laboratory values that preclude treatment with Peg-IFN-alfa or RBV according to the respective local prescribing information
3.Prior exposure to anti-HCV treatment, including any approved or investigational DAA therapy
4.Signs or symptoms of HCC. Serum alpha-fetoprotein (AFP) level and ultrasonography should be available at screening for all subjects (both tests should have been done a maximum of 4 months before the screening visit).
5.History of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results:
a.International Normalized Ratio (INR) of =1.5
b.Serum albumin <3.3 g/dL
c.Serum total bilirubin >1.8 times the upper limit of the laboratory normal range, unless isolated or in subjects with Gilbert’s Syndrome.
6.Coinfection with active hepatitis B or HIV
7.Any of the following laboratory abnormalities (assessed at local laboratory) as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS):
Absolute neutrophil count (ANC) <1,500 cells/mm3
Platelet count <90,000 cells/mm3
Hemoglobin concentration <12 g/dL in females or <13 g/dL in males
Calculated creatinine clearance <50 mL/min
Potassium <3.5 mmol/L
8.Inadequately controlled thyroid function, as judged by the investigator based on the thyroid stimulating hormone (TSH) results
9.Baseline increased risk for anemia (eg, thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic
10.Severe or uncontrolled cardiac disease during the previous 24 weeks
11.Congenital QT prolongation or family history of congenital QT prolongation or sudden death
12.History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
13.History of immunologically mediated disease (eg,autoimmune hepatitis, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis [defined as affecting >10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected], rheumatoid arthritis requiring more than intermittent nonsteroidal anti inflammatory medications for management); in case of patients with both autoimmune and viral hepatitis, the sponsor will make the decision about enrollment.
14.Clinical evidence of chronic pulmonary disease associated with functional impairment
15.History of uncontrolled severe seizure disorders
16.Has a history or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy (eg, cytomegalovirus, macular degeneration)
17.Has a history of major organ transplantation with an existing functional graft with the exception of corneal transplants and skin grafts
18.Pregnant or breast-feeding woman
19.eGFR <30 ml/min/1.73 mq2 or ESRD
20.Use of any medications listed below, within 2 weeks prior to study drug administration: amiodarone, rosuvastatine, proton pump inhibitors at a dosage of omeprazole higher than 20 mg, metotrexate, sulfasalazin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified