Phase IV clinical trial to know the side effects and response of Daclatasvir 60 mg & Sofosbuvir 400 mg tablets in patients with Chronic Hepatitis C genotype 3 infection

Not Applicable

Recruiting

• Conditions: Chronic viral hepatitis C,

• Registration Number: CTRI/2019/11/021975
• Lead Sponsor: Natco Pharma Limited

Brief Summary

The proposed study is an open label, phase IV clinical trial to evaluate the efficacy and safety of Daclatasvir 60 mg & Sofosbuvir 400 mg Tablets in patients with Chronic Hepatitis C genotype 3 infection. Study drugs are formulated as Fixed Dose Combination.

 Chronic infection with hepatitis C virus (HCV) genotype 3 is common throughout the world

and remains a significant disease burden for many patients. Infection with HCV genotype 3 has been associated with an increased risk of progression to cirrhosis, as well as development of steatosis or hepatocellular carcinoma (HCC), compared with other HCV genotypes. DCGI has approved the FDC.

 Daclatasvir 60 mg and Sofosbuvir 400 mg administered to patients who are chronically infected with HCV genotype 3, twelve-week regimen of Daclatasvir plus Sofosbuvir achieved sustained virological response of 90% was achieved. In this phase IV study Fixed Dose combination of Daclatasvir 60 mg and Sofosbuvir 400 mg will be used.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-20
• Last Update Posted: 2021-08-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1.Confirmed chronic HCV with genotype 3 infection (positive HCV genotyping test) 2.Patients with the following haematological and biochemical laboratory variables: A neutrophil count of 1.5 x 109/L, haemoglobin concentration of 11 g/dl or higher in women or 12 g/dl or higher in men, a platelet count of greater than 90 x 109/L, total bilirubin within two times the upper limit of normal (21 µmol/L), ALT less than or equal to 10 times the upper limit of normal (ULN), AST less than or equal to 10 times the ULN 3.Patients who are willing and able to provide written informed consent 4.Patients must follow adequate birth control measures from the date of screening to at least 7 months from the date of stopping the study drug 5.Patients with Compensated liver cirrhosis.

Exclusion Criteria

• Patients with Hepatocellular Carcinoma 2.
• Patients who are pregnant or lactating 3.Patients diagnosed with HIV- I & II Hepatitis B Virus infection, psychiatric illness, unstable pulmonary or cardiac disease seizure disorder or other serious comorbid disorders 4.Decompensated Cirrhosis.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the HCV RNA levels	week 1 week 12 and week 24

Secondary Outcome Measures

Name	Time	Method
Adverse event monitoring	week 1 and week 24

Trial Locations

Locations (4)

Gleneagles Global Clinical Research Services; 🇮🇳 Hyderabad, TELANGANA, India

IPGME&R/SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Regional Institute of Medical Sciences; 🇮🇳 West, MANIPUR, India

Gleneagles Global Clinical Research Services

🇮🇳Hyderabad, TELANGANA, India

Dr Dharmesh Kapoor

Principal investigator

09849439407

dharmesh_kapoor@hotmail.com