E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Patients with chronic hepatitis C and without somatic and/or psychiatric contraindications to treatment will be offered participation in the study in a chronological inclusion procedure. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019744 |
E.1.2 | Term | Hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the rate of sustained virological response at 12 weeks (SVR12) after completion of HCV treatment with the combination of glecaprevir/pibrentasvir in eligible patients attending a needle exchange program. SVR12 is defined as a test result of HCV RNA < LLQ in available samples, i.e. negative tests / per patient who has received at least one dose of study medication.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to investigate the:
i) Number of re-infections/relapses after 12, 24, 36, 48 and 60 months
ii) Completion rate
iii) Adherence to treatment
iv) Virological resistance pattern in failures and at follow-up
v) Effects on health related quality of life (HRQoL) and risk behaviour in active injectors
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Sustained virological response at 12 weeks after completion of therapy (SVR 12). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks after completion of therapy is defined as a test result of HCV RNA < LLQ in available samples, i.e. negative tests / per patient who has received at least one dose of study medication. |
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E.5.2 | Secondary end point(s) |
Completion which is defined as having received study medication for 52 days or more, assessed by pill count, for patients receiving the 8 week regimen, and 77 days or more, for patients receiving the 12 week regimen.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Study medication for 52 days or more, assessed by pill count, for patients receiving the 8 week regimen, and 77 days or more, for patients receiving the 12 week regimen. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |