CompletedNot Applicable

Efficacy of 12 Weeks Versus 24 Weeks Treatment of Directly Acting Antiviral Therapy in Patients With Hepatitis C Related Chronic Liver Disease

Pakistan192 participantsStarted 2024-01-10

Plain-language summary

This randomized controlled trial proposes to compare the treatment outcomes of 12 weeks versus 24 weeks of direct-acting antiviral (DAA) therapy in patients with HCV-related chronic liver disease, addressing the ongoing debate over the ideal treatment duration. To be conducted at the Department of Gastroenterology, Indus Hospital Health Network over nine months, the study will enroll 192 treatment-naive patients (96 per group) aged over 16 with chronic HCV, while excluding those with hepatocellular carcinoma, decompensated cirrhosis, other liver diseases, prior treatment failure, HBV/HIV co-infection, or various exclusionary lab parameters. Using consecutive sampling and draw randomization, Group A will receive 12 weeks and Group B will receive 24 weeks of a regimen comprising sofosbuvir, daclatasvir, and ribavirin, with all patients followed for 12 weeks post-treatment to assess the primary outcome of sustained virologic response (SVR, defined as HCV RNA \<25 IU/ml). Data will be analyzed in SPSS v25 using t-tests and chi-square tests, with a p-value ≤0.05 considered significant, ultimately aiming to determine whether 12 weeks of therapy is sufficient or whether extending to 24 weeks offers meaningful benefit.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

To include the patients in the study, we screened the high-risk population which included IV drug abusers, positive family history, history of blood transfusions and tooth extraction. We excluded the patients who had HCC, decompensated cirrhosis, CLD other than HCV, HCV treatment failure or HCV Relapse, chronic HBV or HIV infection, alanine aminotransferase (ALT) ≥ 5 x upper limit of normal, total bilirubin ≥ 2 mg/dL, international normalized ratio ≥ 1.7, albumin ≤ 3.5 g/dL, hemoglobin ≤ 12 g/dL (females) or ≤ 13 g/dL (males), absolute neutrophil count ≤ 1.5 x 109 cells/L (≤ 1.2 x 109 cells/L for patients of black race); platelets ≤ 90 x 109 cells/L, creatinine clearance ≤ 50 mL/min, alpha fetoprotein \> 100 ng/mL

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sustained Virological Response

Timeframe: SVR at 12 weeks

Trial details

NCT IDNCT07702396

SponsorIndus Hospital and Health Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-20

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