Effect of combination therapy of Pegylated interferon- Alpha 2a, Sofosbuvir and Ribavirin for 12 weeks versus combination of Sofosbuvir and Ribavirin for 24 weeks on viral loads in HCV Genotype 3 chronic hepatitis & compensated cirrhosis patients

Not Applicable

Recruiting

• Conditions: HCV genotype 3 related chronic hepatitis & compensated cirrhosis

• Registration Number: SLCTR/2017/007
• Lead Sponsor: Department of Hepatology Bangabandhu Sheikh Mujib Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1. Age more than 18 years
2. Hepatitis C Virus (HCV) genotype 3
3. Chronic hepatitis/ Compensated Cirrhosis
4. Detectable HCV RNA in blood
5. Platelet count >90,000 /cmm

Exclusion Criteria

1. Decompensated cirrhosis
2. Co-infected with Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV)
3. Hepatocellular carcinoma
4. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained virological response at 12 weeks (SVR 12, defined as undetectability of HCV viral load in blood for 12 consecutive weeks) [At baseline, 28 days after commencement of treatment (RVR), at the end of treatment (ETR) and 12 weeks from the completion of treatment (SVR12)]<br>

Secondary Outcome Measures

Name	Time	Method
Major adverse effects<br><br>i. Any hypersensitivity reaction (determined through patient reports and/or hospital admissions<br><br>ii. Bone marrow suppression (leucopenia, anaemia, thrombocytopenia or pancytopenia as determined by full blood count) <br><br>iii.Sepsis or major infection (determined clinically) [Arm A will be assessed at 1, 2, 4, 8, 12 and 24 weeks, arm B will be assessed at 1, 2, 4, 8, 12, 24 and 36 weeks<br><br> <br>]<br>HCV RNA (viral load) [Arm A will be assessed at 0, 4, 12 and 24 weeks and Arm B will be assessed at 0, 4, 24 and 36 weeks]<br>Complications such as anemia, bleeding manifestations or features of decompensation such as edema, jaundice, ascites and encephalopathy [ ]<br>