Direct Acting Anti-Viral's In Chronic HCV Patients
Study Details
Study Description
Brief Summary
The objective of the study is to determine the safety of DAA's among chronic HCV patients. The outcomes of the study are; To determine the frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon To calculate the percentage of patients with severity of medical event as per Karch and Lasagna classification To determine the percentage of patient having serious adverse event as per ICH Classification
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
The cross sectional survey data will be collected on a pre-defined questionnaire from Gastroenterologist and Hepatologist. The questionnaire will provide us information on demographics, relevant patient history, concomitant medication, ongoing treatment plan recommended for chronic HCV and adverse event details.
The questions related to Pharmacovigilance and safety assessment includes the International Nonproprietary Names (INN) unless it is prescribed brand of Getz Pharma. All adverse events associated with the prescribed treatment will be recorded. Data on outcome assessment will be based on action taken due to AE and other reported details. Seriousness of adverse event will also be recorded as per the ICH classification and severity of medical event will be assessed as per Karch and Lasagna classification.
All the information will be recorded by the healthcare professionals on the questionnaire during direct interaction with the patients.
Patients' written authorization to use and/or disclose the patient's personal and/or health data will be obtained. However, patient data secrecy will follow ICH GCP requirements.
Study Design
Outcome Measures
Primary Outcome Measures
- Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon [12 months]
Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon
Secondary Outcome Measures
- Percentage of patients reported severity of medical event as per Karch and Lasagna classification [12 months]
Percentage of patients reported severity of medical event as per Karch and Lasagna classification
Other Outcome Measures
- Percentage of patient having serious adverse event as per ICH Classification [12 months]
Percentage of patient having serious adverse event as per ICH Classification
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent
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Male or Female patient
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Age of patient ≥18 years
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Patients already diagnosed with HCV and on DAAs therapy.
Exclusion Criteria:
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Written informed consent
-
Male or Female patient
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Age of patient ≥18 years
-
Patients already diagnosed with HCV and on DAAs therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Liver Center Faisalabad | Faisalabad | Punjab | Pakistan |
Sponsors and Collaborators
- Getz Pharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GTZ-NLRF-001