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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis c||Drug: Direct Acting Antivirals||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50000 participants|
|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|
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
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
- 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
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, DMfirstname.lastname@example.org|
|Post Graduate Institute of Medical Education and Research||Recruiting|
|Chandigarh, India, 160012|
|Contact: Radha K Dhiman, DM 911722756335 email@example.com|