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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04242433
Other study ID # IEC-2018-867
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 16, 2017
Est. completion date August 2021

Study information

Verified date January 2020
Source Postgraduate Institute of Medical Education and Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. The efficacy of NS5A inhibitors for the treatment of patients chronically infected with hepatitis C virus (HCV) can be affected by the presence of NS5A resistance-associated substitutions (RASs). Pre-existence of resistance associated substitutions (RASs) to direct antiviral agents (DAAs) reduces sustained virologic response (SVR) rates by 3-53% in hepatitis C virus (HCV) genotype 3 infected patients depending on different predictors and the DAA regimen used. This study will prospectively analyze data from the MukhMantri Punjab Hepatitis C Relief Fund (MMPHCRF) to determine the posttreatment prevalence of various NS5A RASs, and their effect on outcomes of treatment with daclatasvir-sofosbuvir or sofosbuvir-ledipasvirin patients with chronic HCV.

The study aims to assess the prevalence and effect of RASs on sustained virological response (SVR) rates in patients with treatment failure to a regimen containing sofosbuvir and ledipasvir/daclatasvir.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- All viremic chronic hepatitis C

Exclusion Criteria:

- People with disseminated malignancy, advanced cardiovascular, 18 pulmonary, or neurological disease with short life expectancy were not enrolled

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Direct Acting Antivirals
All subjects with viremic chronic hepatitis C will be given DAAs based on the MMPHCRF Treatment algorithm. Patients will be assessed for cirrhosis, prior treatment exposure, high risk groups like dialysis patients, HIV-HCV coinfection, etc. Accordingly treatment will be provided at any of the 25 peripheral centres or at the apex nodal treatment centre (PGIMER) of the MMPHCRF. Baseline and post treatment RAS samples will be collected with consent.

Locations

Country Name City State
India Post Graduate Institute of Medical Education and Research Chandigarh
India Postgraduate Institute of Medical Education and Research Chandigarh

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Achievement of sustained virological response SVR12 12 weeks after treatment completion
Primary Assessment of RAS 12 weeks after treatment completion 12 weeks after treatment completion
Secondary Assessment of RAS in treatment failures Comparison of variants in those who achieve or fail to achieve SVR12 12 weeks after treatment completion
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