Effectiveness of eight weeks of treatment for chronic hepatitis C virus infectio
Phase 3
- Conditions
- Health Condition 1: K738- Other chronic hepatitis, not elsewhere classified
- Registration Number
- CTRI/2022/03/041368
- Lead Sponsor
- Department of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age >18 years
2.HCV mono-infection or HCV-HIV coinfection
3.Detectable HCV RNA ( >10,000 IU/mL) in serum
4.Chronic HCV infection
5.No evidence of cirrhosis based upon a combination of history, examination, ultrasound, Transient elastography, APRI, FIB-4, Upper GI endoscopy
Exclusion Criteria
1.Presence of cirrhosis
2.HCV-HBsAg coinfection
3.Prior exposure to oral anti-HCV drugs, i.e, DAAs
4.Hepatocellular carcinoma or any other malignancy
5.Portal vein thrombosis
6.High-risk population such as people on maintenance hemodialysis, talassaemic or haemophiliacs, people who inject drugs, men have sex with men, high risk sexual behaviour
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants who have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvirTimepoint: Proportion of participants who have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvir
- Secondary Outcome Measures
Name Time Method The proportion of participants who have completed their planned anti-HCV treatmentTimepoint: Eight (intervention arm) or twelve weeks (standrad arm) after start of anti-HCV drugs