NCT03488485

Brief Summary

Background and Aims: The prevalence of hepatitis C virus infection (HCV) infection in Punjab, India is 3.29%, with an estimated burden of around 650,000 viremic chronic HCV (CHC) patients. The Mukh Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) was launched in June 2016 to provide free treatment to all CHC aiming to eliminate HCV from Punjab. The study assessed the feasibility of decentralized care and efficacy and safety of 12 or 24 weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) ± ribavirin (RBV) in the treatment of CHC patients in a public health care setting.

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
50,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 18, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

4.5 years

First QC Date

March 22, 2018

Last Update Submit

June 13, 2019

Conditions

Chronic Hepatitis c

Keywords

Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRFDirect antivirals, DAAsChronic hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Sustained Virological Response

    HCV RNA Load undetectable

    Up to study completion ( average 12 -24 weeks after therapy)

Secondary Outcomes (1)

  • Serious adverse effects

    Up to study completion ( average 12 -24 weeks after therapy)

Study Arms (1)

DAA arm

OTHER

Direct Acting Antivirals therapy An algorithm was developed using DAA (Sofosbuvir-based regimens to treat all patients (RKD). Non Cirrhotics: Sofosbuvir (SOF)+ Daclatasvir (DCV) for 12-weeks Cirrhotics: Genotype 3 were treated with SOF+DCV+ ribavirin (RBV) for 24 weeks, Non-Genotype 3 patients were treated with SOF+LDV+RBV for 12-weeks or with SOF+LDV for 24-weeks (in RBV intolerant patients).

Drug: Direct Acting Antivirals

Interventions

Direct Acting AntiviralsDRUG

DAAs given in patients with viremic chronic hepatitis C

Also known as: Sofosbuvir, Daclatasvir, Ledipasvir
DAA arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Hepatitis C
  • Age: \>18 years

You may not qualify if:

  • Chronic liver disease of a non-HCV etiology
  • Serum Creatinine \>1.5 mg/dl
  • Evidence of hepatocellular carcinoma or other malignancy
  • Significant cardiovascular, pulmonary, or neurological disease
  • History of solid organ or bone marrow transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Related Publications (2)

  • Premkumar M, Gupta E, Sandhu A, Sharma P, Nain J, Taneja S, Verma N, De A, Duseja A, Grover GS, Dhiman RK. Impact of Resistance Associated Substitutions and Predictors of Treatment Failure Following Direct-acting Antiviral Therapy in a Viral Hepatitis C Elimination Cohort. J Clin Exp Hepatol. 2025 Nov-Dec;15(6):102601. doi: 10.1016/j.jceh.2025.102601. Epub 2025 May 28.

    PMID: 40611935DERIVED

  • Premkumar M, Dhiman RK, Duseja A, Mehtani R, Taneja S, Gupta E, Gupta P, Sandhu A, Sharma P, Rathi S, Verma N, Kulkarni AV, Bhujade H, Chaluvashetty SB, Kalra N, Grover GS, Nain J, Reddy KR. Recompensation of Chronic Hepatitis C-Related Decompensated Cirrhosis Following Direct-Acting Antiviral Therapy: Prospective Cohort Study From a Hepatitis C Virus Elimination Program. Gastroenterology. 2024 Dec;167(7):1429-1445. doi: 10.1053/j.gastro.2024.08.018. Epub 2024 Aug 23.

    PMID: 39181168DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Sofosbuvirdaclatasvirledipasvir

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Central Study Contacts

Radha K Dhiman, DM

CONTACT

911722756335rkpsdhiman@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Real Life Efficacy Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 5, 2018

Study Start

June 18, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 14, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)