Chronic Hepatitis cNCT03488485
Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
A study testing Direct Acting Antivirals in people with Chronic Hepatitis c, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis c
- What is being tested?
- Direct Acting Antivirals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 1 siteIndia
- Study dates
- 18 Jun 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Hepatitis C
- Age: >18 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012
Radha K Dhiman, DM, 911722756335, rkpsdhiman@hotmail.com
About this study
Official title: Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
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.
Read the detailed description
An algorithm was developed using SOF-based regimens to treat all patients (RKD). Genotyping is not recommended for patients without cirrhosis of liver and they are being treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis of liver (Figure 1). Patients with liver cirrhosis and genotype 3 are being treated with SOF+DCV+RBV for 24 weeks, while non-genotype 3 patients are being treated with SOF+LDV+RBV for 12-weeks or with SOF+LDV for 24-weeks (in RBV intolerant patients). SVR-12 is mandatory in all patients. Methods: Decentralized care: All patients are being evaluated and treated at 3 Government Medical Colleges and 22 District Hospitals; they were followed up to 12 weeks post-treatment to look for sustained viral response (SVR-12). Health care worker capacity building: 90 medical specialists were trained in a 4-hr predefined course, followed by online continued medical education sessions by regular Extension for Community Healthcare Outcomes (ECHO) Clinic are being conducted fortnightly. 50 pharmacists, 2 from each of the 25 centres, dispense medicine as per specialist prescription. Data Management: 25 trained data entry operators and Clinton Health Access Initiative (CHAI) are managing epidemiological data on CHC hotspots, high-risk groups, local service providers, etc. Monitoring: Medical alerts are being used for compliance monitoring. Study design: A cost-effective algorithm has been developed using SOF-based regimens to treat all patients. The diagnosis of cirrhosis is based on clinical evidence including Aspartate Transaminase (AST)-to-platelet ratio index (APRI ≥ 2.0) and FIB-4 score (>3.25) or on liver stiffness measurement (LSM) ≥12.5 kilopascal (kPa) on fibroscan. The study aims to validate the efficacy and safety of generic all oral Direct Acting Antiviral (DAA) regimens in a decentralized algorithm based public health model in Punjab, India regardless of genotype/presence of cirrhosis.
- Conditions
- Chronic Hepatitis c
- Being tested
- Direct Acting Antivirals
- Keywords
- Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF, Direct antivirals, DAAs, Chronic hepatitis C
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Acting AntiviralsDrug
Also called Sofosbuvir, Daclatasvir, Ledipasvir
DAAs given in patients with viremic chronic hepatitis C
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Direct Acting Antivirals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virological Response
HCV RNA Load undetectable
Measured: Up to study completion ( average 12 -24 weeks after therapy)
Secondary outcomes (1)
Serious adverse effects
Assessment of drug related adverse effects, clinical events, decompensation of liver disease
Measured: Up to study completion ( average 12 -24 weeks after therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start18 Jun 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis cStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Real Life Efficacy Study
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Directorate of Health and Family Welfare, Punjab
- Responsible party
- Principal investigator, Radha K Dhiman, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488485
- Sponsor's protocol ID
- IEC/2018/000324
- Status last verified
- Jun 2019
- First submitted
- 22 Mar 2018
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40611935Premkumar 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.
PubMed 39181168
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
- ClinicalTrials.gov ID
- NCT03488485
- Acronym / sponsor ID
- IEC/2018/000324
- Conditions
- Chronic Hepatitis c
- Keywords
- Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF, Direct antivirals, DAAs, Chronic hepatitis C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Directorate of Health and Family Welfare, Punjab
- Study start
- 18 Jun 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An algorithm was developed using SOF-based regimens to treat all patients (RKD). Genotyping is not recommended for patients without cirrhosis of liver and they are being treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis of liver (Figure 1). Patients with liver cirrhosis and genotype 3 are being treated with SOF+DCV+RBV for 24 weeks, while non-genotype 3 patients are being treated with SOF+LDV+RBV for 12-weeks or with SOF+LDV for 24-weeks (in RBV intolerant patients). SVR-12 is mandatory in all patients. Methods: Decentralized care: All patients are being evaluated and treated at 3 Government Medical Colleges and 22 District Hospitals; they were followed up to 12 weeks post-treatment to look for sustained viral response (SVR-12). Health care worker capacity building: 90 medical specialists were trained in a 4-hr predefined course, followed by online continued medical education sessions by regular Extension for Community Healthcare Outcomes (ECHO) Clinic are being conducted fortnightly. 50 pharmacists, 2 from each of the 25 centres, dispense medicine as per specialist prescription. Data Management: 25 trained data entry operators and Clinton Health Access Initiative (CHAI) are managing epidemiological data on CHC hotspots, high-risk groups, local service providers, etc. Monitoring: Medical alerts are being used for compliance monitoring. Study design: A cost-effective algorithm has been developed using SOF-based regimens to treat all patients. The diagnosis of cirrhosis is based on clinical evidence including Aspartate Transaminase (AST)-to-platelet ratio index (APRI ≥ 2.0) and FIB-4 score (>3.25) or on liver stiffness measurement (LSM) ≥12.5 kilopascal (kPa) on fibroscan. The study aims to validate the efficacy and safety of generic all oral Direct Acting Antiviral (DAA) regimens in a decentralized algorithm based public health model in Punjab, India regardless of genotype/presence of cirrhosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Real Life Efficacy Study
| Arm | Type | Receives |
|---|---|---|
| DAA arm | Other | Drug: Direct Acting AntiviralsDirect 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Hepatitis C
- Age: >18 years
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Acting AntiviralsAlso: Sofosbuvir, Daclatasvir, LedipasvirDAAs given in patients with viremic chronic hepatitis C | Drug | DAA arm |
Primary outcome
Sustained Virological Response
Time frame: Up to study completion ( average 12 -24 weeks after therapy)
HCV RNA Load undetectable
1 secondary outcome
Serious adverse effects
Time frame: Up to study completion ( average 12 -24 weeks after therapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Derived from this study: PubMed 40611935Premkumar 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.
- Derived from this study: PubMed 39181168Premkumar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Acting Antivirals in people with Chronic Hepatitis c, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radha K Dhiman, DM (911722756335, rkpsdhiman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virological Response (time frame: Up to study completion ( average 12 -24 weeks after therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488485, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.