Status:
COMPLETED
A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study
Lead Sponsor:
University of Dundee
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Hepatitis C is a blood borne virus that can seriously damage the liver. An estimated 50,000 Scots have been infected with Hepatitis C virus (HCV). The main driver for spread of HCV infection is intrav...
Detailed Description
Hepatitis C is a blood borne virus that can seriously damage the liver. An estimated 50,000 Scots have been infected with Hepatitis C virus (HCV). The main driver for spread of HCV infection is intrav...
Eligibility Criteria
Inclusion
- Male or Female. (Age limit 18-70)
- HCV PCR confirmed active infection, genotype 1 or 3.
- If female, must have negative urine test results for pregnancy during initial screening period (for trial inclusion) and be advised of limited safety data in pregnancy.
- Current illicit drug use established through participant history.
- Able to provide informed consent, agreeing to trial and clinical monitoring criteria
Exclusion
- Aggressive or violent behaviour.
- Platelet count \< 75000000000 /ml
- Alanine transaminase \> 350 Units/l
- Inability to provide informed consent.
- Clinical history or abnormal valves for albumin\< 30 g/l, Bilirubin \>35 umol/l or prothrombin time \>1.5 consistent with decompensated liver failure Childs-Pugh B or C
- Clinical history of primary hepatocellular carcinoma
- Pregnancy or breast feeding.
- Participation in a drug trial within the previous 30 days
- Hepatitis B surface antigen positive
- HIV infection.
- Hypersensitivity to elbasvir and grazoprevir
- Hypersensitivity to sofosbuvir (genotype 3 infected-participants ony)
- Currently being treated with an inhibitor of organic anion transporting polypeptide 1B, e.g. rifampicin, atazanavir, daruavir, lopinavir, saquinavir, tipranavir, cobicistat or ciclosporin.
- Currently being treated with inducers of cytochrome P450 3A or P-glycoprotein, such as efavirenz, phenytoin, carbamazepine, bosentan, etravirine, modafinil or St John's Wort (Hypericum perforatum)
- Currently being treated with amiodarone (Participants infected with genotype 3 HCV only)
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2020
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03236506
Start Date
January 19 2018
End Date
October 28 2020
Last Update
November 18 2021
Active Locations (2)
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1
University of Dundee
Dundee, Tayside, United Kingdom, DD1 9SY
2
NHS Tayside
Dundee, United Kingdom, DD1 9SY