A prospective open label study to evaluatetreatment of chronic HCV infection with glecaprevir/pibrentasvir in PWID attending a needle exchange program

Phase 1

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

• Registration Number: EUCTR2017-002008-28-SE
• Lead Sponsor: Region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-17
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Registered in the Malmö Needle Exchange Program.
2.Recent injection drug use (within the last 6 months)
3.Written informed consent for participation in the study
4.Chronic HCV infection (as defined above)
5.Female participants must be either postmenopausal, or permanently surgically sterile or, for women of childbearing potential, practicing at least one protocol specified method of birth control (Appendix B) starting at study day 1 through at least 30 days after the last dose of study drug.

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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Female subjects who are pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
2.Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
3.Screening laboratory analyses showing any of the following abnormal laboratory results:
•ALT and/orAST > 10 x ULN
•Platelets <60,000 cells per mm3 for patients with cirrhosis or < 90,000 cells per mm3 for patients without cirrhosis
4.Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 6 weeks (whichever is longer) prior to study drug administration.
5.Decompensated cirrhosis (Child-Pugh B-C).
6.Previous use of any HCV treatment
7.Requirements for and inability to safely discontinue the prohibited medications or supplements listed below at least 2 weeks or 10 half-lives (whichever is longer) prior to the first dose of the study drug.
•Red yeast rice (monacolin K), St. John's Wort
•Carbamazepine, dabigatran, efavirenz, phenytoin, pentobarbital, phenobarbital, primidone, rifabutin, rifampin
•Atorvastatin, lovastatin, or simvastatin should not be taken with the study drug. Subjects receiving these statins should either (a) switch to pravastatin or rosuvastatin at least 14 days or 10 half-lives (whichever is longer) prior to the first dose of study drug or (b) may interrupt statin therapy throughout the treatment period beginning at least 14 days or 10 half-lives (whichever is longer) prior to the first dose of study drug and until 14 days after the last dose of study drug, based on investigator's judgment. If switching to or continuing pravastatin or rosuvastatin, it is recommended to reduce the pravastatin dose by 50% or limit the rosuvastatin dose to 10 mg QD when taking with the study drug
•Astemizole, cisapride, terfenadine
•Hormonal contraceptives or hormone replacement therapy containing ethinyl estradiol
8.Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs and laboratory profile that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:
?Uncontrolled diabetes as defined by a glycated hemoglobin (hemoglobin A1C)
level > 8.5% at the Screening Visit.
?Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
?Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection.

Study & Design

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