An interventional study of Epclusa (nucleotide HCV NS5B polymerase inhibitors). in Hepatitis C, sponsored by Queen Mary University of London. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Queen Mary University of London · Not applicable, Interventional, and Treatment
This trial is linked to a largescale observational study determining the efficacy of sofosbuvir/daclatasvir in people in Pakistan (involving a separate protocol). The observational study will identify a cohort of patients who have not responded to first-line antiviral therapy (sofosbuvir plus daclatasvir) and the optimal treatment for these patients is unclear. This trial will address this issue by comparing two second-line treatment regimens to determine the preferred treatment option.
Chronic infection with the hepatitis C virus (HCV) causes liver damage and, in many, liver cancer. We have effective drugs allowing us to cure most infected people and this stops the liver becoming damaged. Hepatitis C is common in Pakistan and the government is planning a massive national program to find and treat everyone who is infected. The government funded treatment program will fund therapy and assumes that the drugs will cure the vast majority of infected people and hence, in line with international recommendations, they are not planning to evaluate treatment outcomes. The efficacy of the drugs used in Pakistan (sofosbuvir plus daclatasvir) have not been widely assessed in the Pakistani population and their efficacy is not yet proven. In a separate protocol the efficacy of first line therapy in Pakistan will be determined and this study will examine the optimal management for people who have not responded.
This trial will determine optimal treatment regimens in resource poor settings by comparing two affordable, readily available treatment options. 268 patients who meet the inclusion criteria and who accept participation will be enrolled. These patients will be randomly allocated to two equal sized groups (134 per group) and allocated 1:1 (stratified by the presence or absence of cirrhosis) to receive: i) 12 weeks treatment with sofosbuvir/velpatasvir or ii) 24 weeks treatment with sofosbuvir/velpatasvir. An additional 50 patients with decompensated cirrhosis will form a third observational group iii) who will receive 24 weeks of sofosbuvir/velpatasvir. Patients will be assessed for sustained virological response (SVR) from the point of randomisation at 12 (+/-1 week) and 24 weeks (+/-1 week) and then finally at 36 weeks (+/-2 weeks).
The study outline is as follows:
1) HCV patients who fail to respond to the first-line therapy regime will be identified via sustained virological response (SVR) assessment 12 weeks (range 11-18 weeks) after completion of a course of all oral antiviral therapy with sofosbuvir plus daclatasvir for either 12 or 24 weeks with or without ribavirin provided by a recognized provider of health care in Pakistan.
Once enrolled, the 268 patients accepted into the study will be randomly allocated into two groups (134 patients per group) using a computerised 1:1 randomisation programme (stratified by the presence or absence of decompensated cirrhosis) to receive:
i) sofosbuvir(400mg/day)/velpatasvir (100mg/day) - 12 weeks ii) sofosbuvir(400mg/day)/velpatasvir (100mg/day) - 24 weeks
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
This study's planned enrollment of 318 is above the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Queen Mary University of London is the lead sponsor of 253 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have undergone, or be willing to undergo, an approved screening test for determining liver cirrhosis either by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
134 first-line treatment failure patients randomly allocated to receive 12 weeks treatment with sofosbuvir/velpatasvir. 1:1 random allocation with stratification for the presence of cirrhosis
Drug: Epclusa (nucleotide HCV NS5B polymerase inhibitors).
134 first-line treatment failure patients randomly allocated to receive 24 weeks treatment with sofosbuvir/velpatasvir. 1:1 random allocation with stratification for the presence of cirrhosis
Drug: Epclusa (nucleotide HCV NS5B polymerase inhibitors).
50 patients with decompensated cirrhosis who will receive 24 weeks of sofosbuvir/velpatasvir.
Sofosbuvir (400mg/day) and Velpatasvir(100mg/day) for 12 weeks or 24 weeks
Also known as: Sofosbuvir 400 Mg and Velpatasvir 100 Mg Oral Capsules
Determine sustained virological response rate (SVR)
Sustained virological response (SVR) defined as proportion of patients who are HCV RNA negative with a sensitive molecular test (sensitivity \<100 IU/ml) 36 +/- 2 weeks from the time of randomisation. 2\. To determine the proportion of people with decompensated cirrhosis who achieve a sustained virological response (SVR) 36 weeks (+/-2 weeks) after first dose of medication (sofosbuvir/velpatasvir) administered.
Time frame: 36+/- 2 weeks from the point of randomisation
Cost effectiveness of treatment
Cost-effectiveness analysis of retreatment with 12 or 24 week of sof/Vel compared to the standard of care of no re-treatment. Therefore, is it better to accept a lower success rate at lower cost or better to pay more for a few extra SVRs. We will measure the costs of treatment, lab tests, clinician/nurse team for the 12 and 24 week option and any standard of care disease monitoring (without treatment) and will include estimates of the costs of disease care for those not getting treated. We will measure health benefits in terms of DALYs averted or QALYs saved which will be estimated with a disease progression (and possibly transmission) model.
Time frame: 24 weeks after randomisation
Health care costs
To determine the health care costs associated with the different regimens in people with differing degrees of fibrosis.
Time frame: 24 weeks after randomisation
Determine viral polymorphisms in HCV
To determine viral polymorphisms in HCV that are associated with a reduced response to antiviral therapy.
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jun 2023 (actual). Primary completion is estimated for Sep 2027, 51 months after the start.
Of 150 non-industry interventional studies with no phase under Hepatitis C, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 51 months is above that.
Counting every sponsor, half of 153 studies reached it within 25 months; a quarter within 14 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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