Liver Center Faisalabad
Faisalabad, Punjab Province, Pakistan
NCT Number: NCT04664894
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
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Notify Me18 year and older
All sexes
Observational
Faisalabad, Punjab Province, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the occurrence of AEs (AE) and their severity among chronic HCV patients has assessed in patinets receiving different combinations of DAAs in Pakistani Population
Other names: Daclatasvir, Ribavirin, Velpatasvir
Time frame: 12 months
Frequency of adverse events while receiving DAAs with or without RBV and/or Pegylated Interferon
Time frame: 12 months
Percentage of patients reported severity of medical event as per Karch and Lasagna classification
Time frame: 12 months
Percentage of patient having serious adverse event as per ICH Classification
Getz Pharma
Industry
New Drugs And New Concerns: Gaining Insight Through Pharmacovigilance Of Direct Acting Anti-Viral's In Chronic HCV Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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