- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03488485
Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
Efficacy of Decentralized Care in the Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Radha K Dhiman, DM
- Phone Number: 911722756335
- Email: rkpsdhiman@hotmail.com
Study Locations
-
-
-
Chandigarh, India, 160012
- Recruiting
- Post Graduate Institute of Medical Education and Research
-
Contact:
- Radha K Dhiman, DM
- Phone Number: 911722756335
- Email: rkpsdhiman@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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). |
DAAs given in patients with viremic chronic hepatitis C
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained Virological Response
Time Frame: Up to study completion ( average 12 -24 weeks after therapy)
|
HCV RNA Load undetectable
|
Up to study completion ( average 12 -24 weeks after therapy)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to study completion ( average 12 -24 weeks after therapy)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Anti-Infective Agents
- Sofosbuvir
- Antiviral Agents
- Ledipasvir
Other Study ID Numbers
- IEC/2018/000324
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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