Second chance for hepatitis c cure: new trial tests best retreatment
NCT ID NCT05248919
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for people in Pakistan with hepatitis C who did not get cured by their first treatment. It compares two different lengths of treatment with the drug Epclusa (12 weeks vs 24 weeks) to see which works better. About 318 adults will take part, and the goal is to find the safest and most effective way to clear the virus in this group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sofosbuvir and Velpatasvir (Epclusa)
- What this could lead to
- If successful, this trial could identify the best retreatment strategy for people with hepatitis C who did not get cured by first-line therapy, potentially improving cure rates in this group.
- What could go wrong
- This is a relatively small, non-randomized study in one region of Pakistan, so results may not apply broadly. The treatments are already approved, so the main question is which duration works best, not a breakthrough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 318 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing and able to give written informed consent or sign consent forms with a fingerprint. * Male or female, age ≥ 18 years. * Willing to comply with study procedures * Resident in the area and not planning to leave the region. * Have a confirmed diagnosis at the time of screening of active hepatitis C infection - defined as detectable HCV RNA using a molecular diagnostic assay with a sensitivity of \>100IU/ml OR detectable HCV Core antigen using an assay with a sensitivity of \>1.5 pg/ml. * Treatment experience within the last 24 months of antiviral therapy drugs recommended by the government program and administered in line with national recommendations. The current recommendations are that patients without cirrhosis should receive sofosbuvir 400 mg per day in combination with daclatasvir 60 mg per day for a total of 12 weeks and for patients with cirrhosis therapy should involve sofosbuvir 400 mg per day in combination with daclatasvir 60 mg per day for a total of 24 weeks. Patients who receive additional medication (including ribavirin) can be enrolled in the study but the additional medication should be noted. * The subject's medical records must include sufficient detail of prior treatment to confirm eligibility. * Have a stored sample of serum or plasma that is known to contain detectable HCV RNA and which can be made available to the study team or be willing to provide such a sample * Have undergone, or be willing to undergo, an approved screening test for determining liver cirrhosis either by: 1. APRI score - calculated from serum AST concentration in IU/L and platelet count /L (a result of ≥2 demonstrates presence of cirrhosis) 2. Liver transient elastography assessment (a 'Fibroscan'). A result of ≥12.5 kPa will demonstrate cirrhosis. 3. liver biopsy within 1 year of screening * Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to enrolment. * Lactating females must agree to discontinue nursing before starting study drug. * Subjects must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments. Exclusion Criteria: * Unwilling or unable to give consent * Clinically significant illness (other than HCV) or other major medical condition that may interfere with the subject's treatment, assessment or compliance with protocol. * History of discontinuation the most recent regime due to an adverse event * Co-morbidities limiting life expectancy to less than 12 months * Gastrointestinal disorder that could interfere with the absorption of the study drugs * Significant cardiac disease * Unstable psychiatric condition * Significant drug allergy (e.g. hepatotoxicity) * Infection with hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) * Unable or unwilling to undergo the necessary procedures - undergoing blood testing and ultrasound/fibroscan scanning. * Previous poor compliance with medication (defined as failure to take \>80% of the prescribed medication) * Have undergone liver or other solid organ transplantation * Have a current or recent diagnosis of hepatocellular carcinoma or any other malignancy
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinical trials unit
Karachi, Sindh, Pakistan
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