Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
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ClinicalTrials.gov Identifier: NCT03488485 |
Recruitment Status : Unknown
Verified June 2019 by Radha K Dhiman, Postgraduate Institute of Medical Education and Research.
Recruitment status was: Recruiting
First Posted : April 5, 2018
Last Update Posted : June 14, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis c | Drug: Direct Acting Antivirals | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50000 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Real Life Efficacy Study |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model |
Actual Study Start Date : | June 18, 2016 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
DAA arm
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
DAAs given in patients with viremic chronic hepatitis C
Other Names:
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- Sustained Virological Response [ Time Frame: Up to study completion ( average 12 -24 weeks after therapy) ]HCV RNA Load undetectable
- Serious adverse effects [ Time Frame: Up to study completion ( average 12 -24 weeks after therapy) ]Assessment of drug related adverse effects, clinical events, decompensation of liver disease

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic Hepatitis C
- Age: >18 years
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488485
Contact: Radha K Dhiman, DM | 911722756335 | rkpsdhiman@hotmail.com |
India | |
Post Graduate Institute of Medical Education and Research | Recruiting |
Chandigarh, India, 160012 | |
Contact: Radha K Dhiman, DM 911722756335 rkpsdhiman@hotmail.com |
Responsible Party: | Radha K Dhiman, Professor, Postgraduate Institute of Medical Education and Research |
ClinicalTrials.gov Identifier: | NCT03488485 |
Other Study ID Numbers: |
IEC/2018/000324 |
First Posted: | April 5, 2018 Key Record Dates |
Last Update Posted: | June 14, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Mukh Mantri Punjab Hepatitis C Relief Fund,MMPHCRF Direct antivirals, DAAs Chronic hepatitis C |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Sofosbuvir Antiviral Agents Ledipasvir Anti-Infective Agents |