NCT04242433

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3.5 years

First QC Date

October 7, 2019

Last Update Submit

January 22, 2020

Conditions

Hepatitis CPublic HealthDirect Acting Antiviral AgentsResistance Associated Substitutions

Keywords

Resistance associated substitutionsHCV

Outcome Measures

Primary Outcomes (2)

  • Achievement of sustained virological response

    SVR12

    12 weeks after treatment completion

  • Assessment of RAS

    12 weeks after treatment completion

    12 weeks after treatment completion

Secondary Outcomes (1)

  • Assessment of RAS in treatment failures

    12 weeks after treatment completion

Study Arms (1)

Viremic Person living with HCV

All persons enrolled in the MMPHCRF treatment programme are provided free of charge direct acting antiviral agents and followed up for outcomes.

Drug: Direct Acting Antivirals

Interventions

Direct Acting AntiviralsDRUG

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.

Viremic Person living with HCV

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The MMPHCRF Cohort patients are treated at 25 sites in Punjab State India with algorithm based DAAs for chronic Hepatitis C.

You may qualify if:

  • All viremic chronic hepatitis C

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum will be stored with HCV RNA samples in the institutions's secure facility

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2019

First Posted

January 27, 2020

Study Start

July 16, 2017

Primary Completion

January 1, 2021

Study Completion

August 1, 2021

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

IN(2)